NASD Regulation of IPO Conflicts of Interest - Does Gatekeeping Work

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美国FDA指导原则无产品标识的产品包装和同质箱的父化策略英文原版

美国FDA指导原则无产品标识的产品包装和同质箱的父化策略英文原版Title: FDA Guidance on Product Labeling and Homogeneous Packages' Branding StrategyIntroduction:The Food and Drug Administration (FDA) in the United States provides guidance on various aspects of product labeling and branding strategies. This article aims to discuss the FDA's guidance regarding products without proper labeling and the branding strategy for homogeneous packages.FDA Guidance on Products without Proper Labeling:1. General Requirements:The FDA requires all products distributed or sold in the United States to be properly labeled with essential information. Such information includes the product's name, ingredient list, warnings, directions for use, and contact information of the manufacturer or distributor. For products without proper labeling, the FDA guidance suggests the following:2. Relabeling and Repackaging:The FDA guidance also provides instructions on relabeling and repackaging of products without proper labeling. Key points include:a. Reputability of the relabeling/repackaging process: The process of relabeling or repackaging must adhere to strict guidelines to ensure it is reputable, accurate, and in accordance with applicable regulations. This may requireguidance from the FDA or qualified experts.b. Resolving misbranding: Relabeling must correct the misbranding issue by providing all the necessary information and meeting FDA labeling requirements.c. Record-keeping: Manufacturers and distributors must maintain proper records of the relabeling or repackaging process, including any change in labeling, raw material sourcing, or manufacturing details.Brand Identity Strategies for Homogeneous Packages:1. Definition of Homogeneous Packages:2. Branding and Identification:a. Individual unit identification: Each individual unitwithin homogeneous packaging must maintain its own identity, allowing for easy identification of the product, its ingredients, and any necessary warnings. This promotes transparency and enables consumers to make informed decisions.b. Group identification: Homogeneous packages should also bear group identification labeling, highlighting the shared characteristics of the individual units contained within thepackaging. This assists consumers in understanding the relationship between the units and reinforces the brand identity and consistency.c. Clear packaging design: The packaging design should facilitate quick and accurate identification of the product inside and must not mislead consumers about the contents or quality of the product.Conclusion:。

药品再注册审查管理规程英文版

药品再注册审查管理规程英文版Drug Re-registration Review and Management Regulations (English Version)Article 1These Regulations are formulated in accordance with the “Regulations on the Administration of Pharmaceutical Products”(hereinafter referred to as the Regulations) and other relevant laws and regulations, in order to regulate the administration of drug re-registration, and to ensure the safety and effectiveness of drug circulation and use.Article 2The National Medical Products Administration (hereinafter referred to as the NMPA) is responsible for the unified management of drug re-registration in the country. The local Medical Products Administration (hereinafter referred to as the LMA) is responsible for the management of drugre-registration in its respective area.Article 3Drug re-registration generally refers to the review and approval of the registration documents of pharmaceutical products that are about to expire, with the purpose of renewing their registration. The scope of drug re-registration shall besubject to the regulations of the registration certificate issued by the NMPA. The applicant shall be the original holder of the registration certificate.Article 4The applicant for the drug re-registration shall submit the following documents to the NMPA for review and approval:1. Drug re-registration application form.2. The original registration certificate and its copy.3. Product quality management documents including product formula, process flow chart, raw materials list, technical requirements, inspection standards, etc.4. Product quality inspection reports.5. Product packaging and label design.6. Other documents required by the NMPA.Article 5The NMPA shall, within 15 working days of receiving the application for drug re-registration, examine the application documents in accordance with the Regulations, and decide whether to approve or reject it.Article 6The applicant shall, within 6 months prior to the expiration of the registration certificate, submit theapplication for drug re-registration to the NMPA. Any application submitted after the expiration of the registration certificate shall not be accepted.Article 7After the NMPA approves the application for drugre-registration, it shall issue a new registration certificate to the original certificate holder. The newly issued registration certificate shall have the same validity period as the original certificate.Article 8For any major changes in the production process, formulation, packaging and labeling, etc., of a product for which a registration certificate has been issued, the holder of the registration certificate shall apply for a change in the registration certificate.Article 9The NMPA may, according to the actual situation of the drug re-registration, carry out spot checks on the applicant’s products and production sites, and entrust third-party organizations to carry out product quality and safety tests. Article 10These Regulations shall come into force on the date ofpromulgation. Any other regulations or local regulations which are inconsistent herewith shall be repealed simultaneously.。

巴拿马航运法律概览

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Acknowledgements
JOSEPH & PARTNERS KINCAID – MENDES VIANNA ADVOGADOS ASSOCIADOS LAW OFFICES CHOI & KIM LEXCELLENCE LAW FIRM MORAIS LEITÃO, GALVÃO TELES, SOARES DA SILVA & ASSOCIADOS, RL MORGAN & MORGAN PALACIOS, PRONO & TALAVERA PRAMUANCHAI LAW OFFICE CO, LTD RAJAH & TANN LLP RUGGIERO & FERNANDEZ LLORENTE S FRIEDMAN & CO SABATINO PIZZOLANTE ABOGADOS MARÍTIMOS & COMERCIALES SAN SIMÓN & DUCH SEWARD & KISSEL LLP STUDIO LEGALE MORDIGLIA VERALAW (DEL ROSARIO RABOCA GONZALES GRASPARIL) VGENOPOULOS & PARTNERS LAW FIRM YOSHIDA & PARTNERS
The Shipping Law Review
The Shipping Law Review
Editors James Gosling and Rebecca Warder
Law Business Research
The Shipping Law Review
The Shipping Law Review Reproduced with permission from Law Business Research Ltd. This article was first published in The Shipping Law Review - Edition 1 (published in July 2014 – editors James Gosling and Rebecca Warder). For further information please email Nick.Barette@

禁止垄断协议行为的规定中英文对照版

禁止垄断协议行为的规定中英文对照版工商行政管理机关禁止垄断协议行为的规定Rules of AIC on Prohibition of Monopoly Agreements第一条为了制止经济活动中的垄断协议行为，根据《中华人民共和国反垄断法》（以下简称《反垄断法》），制定本规定。

Article 1 These Rules are formulated in accordance with the Anti-Monopoly Law of the People’s Republic of China (hereinafter referred to as “AML”) for purpose of preventing monopoly agreement in economic activities.第二条禁止经营者在经济活动中达成垄断协议。

垄断协议是指违反《反垄断法》第十三条、第十四条、第十六条的规定，经营者之间达成的或者行业协会组织本行业经营者达成的排除、限制竞争的协议、决定或者其他协同行为。

协议或者决定包括书面形式和口头形式。

其他协同行为是指经营者虽未明确订立书面或者口头形式的协议或者决定，但实质上存在协调一致的行为。

Article 2Undertakings are prohibited from reaching any monopoly agreement in economic activities.Monopoly agreements shall mean any agreement, decision and other concerted practice reached among undertakings or organized by industry association that eliminate or restrict competition in violation of Article 13, 14, 16 of the AML.An agreement or decision may take written and oral forms.Other concerted practice shall mean colluded coordination in practice between undertakings without express oral or written agreements or decisions.第三条认定其他协同行为，应当考虑下列因素：（一）经营者的市场行为是否具有一致性；（二）经营者之间是否进行过意思联络或者信息交流；（三）经营者能否对一致行为作出合理的解释。

上市相关英文术语

上市相关英文术语新股发行-IPO(inital public offering)收购兼并-merger and acquisition市场操纵-market manipulation内幕交易-insider trading/insider dealing券商-broker/dealer金融衍生品-financial derivative清算结算-cleaning and settlement市盈率-price/earning ratio市值-market capitalization基金托管银行-fund custodian bank开放式投资基金- open-end securities investment fund 封闭式投资基金- close-end securities investment fund 企业债券-corporate bond国库券-treasury bond 政府债券-government bond可转换债券-convertible bond可流通股份-negotiable share债券-bond/debts/debenture股票-share/stock/equity上市-listed/quoted蓝筹股-blue chip shares经济指标-economic indicator通货膨胀-inflationthe characteristic of legal right合法权力性shareholders' congress股东大会members of the board of directors董事会成员negotiable securities有价证券share interest（dividend）股息bonus红利shareholder股东periodical revenue定期收入pledge抵押品the characteristic of universal circulation普遍流通性the characteristic of monetary speculation金融投机性the price of stock股票价格the characteristic of investment risk投资冒险性issue stocks发行股票subscribe stocks认购股票securities exchange证券交易所investor投资者stockbroker经纪人securities company证券公司to raise funds for the enterprise 为企业筹集资金to be conducive to the decentralization of proprietary rights 有助于所有权的分散to provide a means of equal distribution of social wealth 提供一种平等分配社会财富的手段to promote the long-term investment of international funds 促进国际资金的长期投资to accelerate the turnover of international capital 加速各国之间资金的周转to further the advancement of world economy and international trade 促进世界经济和国际贸易的发展to coordinate international relations 协调国际经济关系executive director of board 执行董事concurrent director of board 兼职董事chairman of the board of directors (general director) 董事主席（董事长）director manager 董事经理permanent director of board 永久董事acting director of board代理董事ordinary shares (common stock) 普通股merit-based shares 优绩股developmental shares 成长股speculative shares 投机股preference shares 优先股accumulative preference shares 累积优先股non- accumulative preference shares非累积优先股transferable preference shares 可调换优先股accumulative- transferable preference shares 累积调换优先股substantial shares 实质股craze shares热门股the par value of shares 股票面值the net value of shares股票净值the market value of shares 股票市值the sum of shares 股份总数the money paid for shares 股金the serial number of shares 股票编号open an account with the stockbroker 开户completion of a business transaction 交割transferring ownership 过户liquidation of stocks 股票的清算crisscross deal 交叉交易selective shares deal 股票选择交易date declare 宣布日date of record 股权登记日date payable 派息日superior shares 优良股buying up 多头short sales (short position) 空头bull market 牛市bear market 熊市opening price 开盘价closing price收盘价suspension of business in case of skyrocketing of stock prices 涨停板suspension of business in case of slump of stock prices 跌停板settlement and compensation 清偿spot transaction (over-the-counter deal) 现货交易credit deal 信用交易forward business (future trades) 期货交易investment trust company 投资信托公司petty investors with limited means 小户投资者principal quotation 主要行情secondary quotation 次要行情routine quotation (blackboard quotation) 日常行情（黑板行情）reasonable quotation 合理行情irrational quotation不合理行情wavering quotation with undercurrent 隐含暗流的徘徊行情Advance-Decline Theory涨跌理论Arbitrage套利Arbitrageur套利者Ask-Bid System竞价系统At-the-Close Order收盘指令At-the-Market按市价At-the-Opening(Opening Only)Order 开盘指令Back Up逆向变化Bar Chart条线图Base Market value基准市场价值Bearish行情看跌Bear Market熊市Bear Raiders大量抛空者Bid-and-Asked Quotation(or Quote) 买方报价和卖方报价（报价）Blowout畅销Breakout突破Bullish行情看涨Bull Market牛市Buying Power购买力Capitalization资本Climax(Buying lling) 放量（买/卖）Closing Transaction 平仓交易Congestion Area震荡区Cornering the Market *纵市场Cum Rights含权Cyclical Stock周期性股票Date of Record登记日Day Order当日委托指令Day Trading日交易Dealer交易商Descending Tops下降顶点趋势Dip回调谷Distribution Area整理区Diversification分散投资Dividends红利Don't Fight the Tape 顺行情交易Double Bottom双底Double Top双顶Dumping抛售Effective Date生效日期Ex-Distribution(X Dis)无分配额Ex-Dividend(XD)(Without Dividend) Date 除息日Expiration Date到期日Ex-Right(XRT)除权Face value面值Floor交易大厅Floor Order Tickets场内委托单Free-Riding自由放纵投机行为Frozen Account冻结账户Fundamental Analysis基本面分析Futures期货Gap跳空Head and Shoulders头肩形Highballing高价交易Holder of Record登记持股人Holding the Market托盘Horizontal Price Movement横盘Hot Issue抢手证券Inactive Market不活跃市场Insider内幕人In the Tank跳水Issued-and-Outstanding Stocks已发行流通股Joint Account联合账户Last Trading Day 最后交易日Liquidation清仓Liquidity流动性Long Market value 所持证券市场价值Long Position多头头寸Manipulation*纵Marketability流动性Matched Orders对敲指令Merger合并NegotiabilityNew Issue新发行Offer要价Offering (Asked) Price 卖方要价Off-Floor Order场外委托On-Floor Order场内委托On the Tape行情显示Opening Only Order 开盘委托指令Opening Transaction 建仓交易Oversold超卖OvervaluedP(rice)/E(arnings) Ratio市盈率Paper Loss/Profit账面损益Pennant尖旗形Picture行情Place发售Portfolio证券组合Position头寸Price Range价格范围Primary Distribution(Offering) 初次发售Primary MarketPrimary Movement大趋势Principals(Stockholders)股东Principal value本金值Profit Taking活力回吐Public Offering(Distribution) 公开发售Purchasing(Buying) Power 购买力Rally反弹Reading the Tape看盘Reorganization资产重组ResistanceResistance level阻挡线Reversal反转Rigged Market受*纵的市场Rising Bottom上升谷底趋势Rounding Bottom(Saucer)圆底Rounding Top圆顶Screen(Stocks)选股Secondary Distribution(Offering) 二次发售Secondary Market二级市场Securities AnalysisSecurity证券Seek a Market寻求入市机会Selling Off(Sell-Off) 止损抛售Short Position空头头寸Soft Market疲软市场Speculation投机Split Down并股Spread价差Stag攫利者滞胀Stagnation萧条Stockholder(Shareholder) 持股人Subion Ratio认购比率Substitution(Swap)替代（互换）Support支撑区Support Level支撑线Sweetener甜头Takeover接管(Ticker) Tape行情显示系统Technical Analysis技术分析Technical Sign技术讯号Tight Market旺市Tip提供消息Total Cost总成本Total Volume总成交量Trade Date交易日Trader交易商Trading Authorization 交易授权Trading Floor交易大厅Trend趋势Trendline趋势线Triangle三角形Undervalued估价过低Unissued Stock未发行股票Uptrend上升趋势Weak Market弱市Wedge楔形W FormationW底coupon rate 券根利率CTA(Commodities Trading Advisor) 农矿产品交易顾问Currency board 货币委员会DAX index （法兰克福）德国股市指数dead loan 死帐delist 从上市证券表中除名derivatives 衍生金融商品（由利率或债券、外汇或汇率以及股票或股价指数等现货市场衍生出来，主要有期货futures、期权option trading与掉期swap三种类型，品种多达100余种。

媒体应该有审查制度英语作文

媒体应该有审查制度英语作文In the modern era, where information is disseminated at an unprecedented pace, the role of media is more critical than ever. The question of whether the media should have a censorship system has sparked vigorous debate. On one hand, proponents of censorship argue that it can prevent the spread of misinformation, protect vulnerable audiences, and maintain social order. On the other hand, critics contend that censorship infringes upon freedom of speech and can lead to government control over public opinion.One of the primary reasons for implementing a censorship system is to ensure that the public is not misled by false information. In a world where anyone can publish content online, the potential for misinformation to spread is significant. Media censorship can act as a filter, verifying the accuracy of information before it reaches the public. This can help to prevent panic, confusion, and the erosion of trust in institutions.Another argument in favor of media censorship is the protection of sensitive content from children and other vulnerable groups. Not all content is suitable for all audiences, and censorship can serve as a safeguard to ensure that age-inappropriate or otherwise sensitive material is not accessible to those who should not be exposed to it.Furthermore, censorship can help to maintain socialharmony by preventing the spread of content that could incite violence or social unrest. In societies with a history of conflict, the media can play a crucial role in either exacerbating tensions or promoting peace and reconciliation.A censorship system can help to ensure that the media contributes positively to social stability.However, opponents of media censorship argue that it can be a tool for government control and suppression of dissent. When the government has the power to decide what can and cannot be published, it can manipulate the narrative to suitits own interests, thereby undermining the public's right to know the truth. This can lead to a lack of accountability and a culture of secrecy.Moreover, censorship can stifle creativity and diversityof thought. When journalists and creators are forced to self-censor in order to avoid penalties, the range of ideas and perspectives available to the public becomes limited. Thiscan lead to a homogeneous media landscape that does notreflect the rich tapestry of society.In conclusion, while media censorship has its merits in terms of accuracy, protection, and social stability, it also poses significant risks to freedom of expression anddiversity of thought. Striking a balance between these competing interests is a complex challenge that requires careful consideration of the values that a society holds dear. It is essential to have a robust and transparent system of checks and balances to ensure that the media serves thepublic interest without compromising on the fundamental principles of a free and open society.。

4-关于进一步改革和完善新股发行体制的指导意见（英文）

4-关于进一步改革和完善新股发行体制的指导意见（英文）第一篇：4-关于进一步改革和完善新股发行体制的指导意见(英文) Announcement of the China Securities Regulatory Commission(No. 13 [2009])For purposes of further improving the mechanisms for the issuance of new shares and enhancing the efficiency of issuance, this Commission (CSRC) has formulated the Guiding Opinions on Further Reforming and Improving the Issuance System of New Shares, which are hereby promulgated and shall come into force on June 11, 2009.June 10, 2009Guiding Opinions on Further Reforming and Improving the Issuance System of New SharesIn recent years, under the correct leadership of the CPC Central Committee and the State Council, a series of significant fundamental and systematic reforms have been carried out in China’s capital market, and remarkable achievements have been made. The scale and capacity of the market has reached a new level, the market mechanisms and structure have been gradually optimized, the investors are enthusiastically entering the stock market, various enterprises are eager to make use of the capital market to improve their governance mechanisms and obtain financing, and the importance of the capital market has become increasingly prominent. To further improve the mechanisms and enhance the efficiency, it is necessary to reform and improve the issuance system of new shares to adapt to the greater development of the market. The CSRC hereby puts forward the following guiding opinions on further reforming andimproving the issuance system of new shares after a broad survey and study of the relevant issues on the reform of the issuance system of shares:I. Principles of reform, basic contents and objectives(1) Principles of reform: adhering to the market orientation, further promoting the market pricing of new shares, focusing on developing a market constraint mechanism, promoting the issuers, investors, underwriters and other market participants to perform their respective responsibilities, and paying attention to the will of small- and medium-sized investors to participate.(2) Basic contents: With respect to the pricing of new shares, we shall improve the quotation constraint mechanisms for price inquiry and subscription, weaken the administrative guidance, and form a further market-oriented pricing mechanism. With respect to the issuance underwriting, we shall increase the flexibility of the underwriting and allotment, streamline the underwriting mechanisms, reinforce the binding force of the buyers on sellers and the responsibilities of the underwriters in the issuance, and gradually change the situation of allotting shares in strict accordance with the amount of funds; timely adjust the policies for issuance of shares and increase the amount of tradable shares; optimize the online issuance mechanism, give proper preference to small- and medium-sized investors which intend to subscribe in the share allocation, and alleviate the situation of huge funds swarming for subscription to new shares; improve the claw-back mechanism and the mechanism of suspension of issuance. At the same time, we shall strengthen the warning of risks in subscribing to new shares and clarify risks on the issuance market.(3) Objectives. Firstly, the market function of price discoveryshall be optimized, and the mechanism of internal checks and balances between the buyers and the sellers shall be reinforced. Secondly, the effectiveness of the allotment mechanism of shares shall be enhanced, the situationof huge funds swarming for subscription to new shares shall be alleviated, and the quality and efficiency of issuance shall be improved. Thirdly, under the premise of clarifying risks, we shall give weight to the will of small- and medium-sized investors to participate, and give proper preference to the small- and medium-sized investors which intend to subscribe to new shares. Fourthly, the disclosure of risks shall be strengthened, and the awareness of risks in the primary market shall be reinforced.II. Recent reform measuresSince the issuance system of new shares covers a wide range and has great impacts, in order to ensure the stable progress of the reform, we plans to phase in various reform measures in the manner of implementation step by step and gradual improvement. We mainly advance the following four measures at the present stage:(1) Improving the quotation constraint mechanism for price inquiry and subscription, and forming a further market-oriented pricing mechanism. The inquiry objects shall offer true quotations, the inquiry quotation and subscription quotation shall be logically consistent, and the leading underwriter shall take measures to avoid such situations as offering a high quotation without subscription and offering a low quotation but subscribing at a higher price. The issuer and its leading underwriter shall, according to the scale of issuance and market conditions, reasonably set a minimum subscription amount for each subscription. If the final pricing is beyond the expected price,as a result of which the amount of funds raised exceeds the amount of project funds needed, the issuer shall disclose the related purposes beforehand in the prospectus.(2) Optimizing the online issuance mechanism, and separating the subscribers in the online and offline subscription. In the issuance of each stock, any object of allotment of shares may only choose one form of subscription to new shares: either offline or online, and all objects of allotment of shares which participate in the offline quotation, subscription and allotment of this stock shall not participate in the online subscription.(3) Setting an upper limit for a single online subscription account. The issuer and its leading underwriter shall, according to the scale of issuance and market conditions, reasonably set the subscription upper limit for a single online subscription account, which shall normally not exceed one-thousandth of the shares issued online. A single investor may only use one qualified account to subscribe to new shares.(4) Strengthening the warning of risks in subscription to new shares to alert all participants to the market risks. The issuer and its leading underwriter shall publish a special announcement on risks in investment in new shares, so as to fully disclose the risks on the primary market and prompt the investors to make a rational judgment on the feasibility of making investment in the company. The securities institutions shall take measures to alert the investors to the risks in subscription to new shares.Other reform measures shall be put forward at the right time based on an overall consideration of the market development speed, strength of reform and endurance of the market.III. Effectively implementing various reform measuresThe reform of the issuance system of new shares needs theclose cooperation of all participants inthe market. All the market participants shall raise awareness, formulate corresponding plans, carefully make deployments, and effectively implement all requirements for the reform.The issuers shall have correct concepts of issuance and listing, actively perform the obligation of information disclosure, strengthen the management of the raised funds, enhance the business operation levels of listed companies, and safeguard the lawful rights and interest of shareholders.The underwriters (sponsor institutions) and other securities companies shall perform their functions diligently and in good faith, and protect the long-term and fundamental interests of both buyers and sellers in the business activities. In practice, they shall make improvements and adjustments in terms of institution, personnel, system, technology, etc., and continuously improve their capacities to provide professional services.The price inquiry objects shall play the role of a professional institution, earnestly, prudently and professionally gather, analyze and study data, make rational pricing, and form rational guidance of the market.The investors shall pay full attention to the risk factors in the market-oriented pricing, know that some stocks may see their prices fall below the issue price after listing, tangibly increase their risk awareness, strengthen the concept of value investment and avoid speculation.The relevant self-disciplinary organizations shall take active measures to effectively strengthen the self-disciplinary management of and services for the underwriters, price inquiry objects, objects of allotment of shares and securities companies participating in the issuance of new shares.第二篇：关于进一步深化新股发行体制改革的指导意见关于进一步深化新股发行体制改革的指导意见根据党中央、国务院关于2012年经济工作的部署，深化新股发行体制改革是完善资本市场的重要任务之一。

准入前国民待遇加负面清单英文翻译

准入前国民待遇加负面清单英文翻译1. IntroductionIn recent years, China has been actively promoting the reform of its foreign investment management system. One of the key measures is the implementation of the "national treatment plus negative list" model for market access. This system 本人ms to ensure equal treatment of domestic and foreign investors, while at the same time defining sectors in which foreign investment is restricted or prohibited. This article will provide a brief overview and English translation of the "national treatment plus negative list" policy.2. National TreatmentUnder the "national treatment" principle, foreign investors are to be treated no less favorably than domestic investors in the same industry. This means that once a foreign investor has established a presence in China, they are entitled to the same rights and privileges as Chinesepanies. This includes equal access to government procurement, standard setting, and other aspects of market participation.3. Negative ListThe "negative list" is a keyponent of the market access system. It is aprehensive list that outlines the sectors in which foreign investment is restricted or prohibited. The negative list is regularly updated to reflect changes in government policy and market conditions. By clearly defining the sectors in which foreign investment is restricted, the negative list provides transparency and predictability for foreign investors.4. ImplementationThe "national treatment plus negative list" model has been implemented in various pilot free trade zones across China. These zones serve as testing grounds for new policies before they are rolled out nationwide. The implementation of this model has led to increased foreign investment in these zones, as well as greater clarity and cert本人nty for foreign investors.5. English TranslationThe "准入前国民待遇加负面清单" model is often translated into English as "national treatment plus negative list." This translation accurately captures the essence of the policy - equal treatment for domestic and foreign investors, with specific restrictions outlined in the negative list. The English translation is widely used in official government documents, as well as inacademic and business contexts.6. ConclusionThe "national treatment plus negative list" model represents a significant step forward in China's efforts to open up its markets to foreign investment. By providing equal treatment for domestic and foreign investors, while also clearly defining restricted sectors, this policy has increased transparency and predictability for foreign investment. As China continues to refine and expand this model, it is likely to further attract foreign investment and contribute to the country's economic development.。

《上海市经营者反垄断合规指引》英语版

Shanghai Anti-Monopoly1 2 4 5 6 7About this Guide p1About the Anti-monopoly Law ofthe People's Republic of China p2 Legal Liabilities p3 How to Ensure Compliance p4 Identiﬁcation and Prevention of Monopolistic Conducts p6 Investigation into Suspected Monopolistic Conducts p20 Legal Documents p243Contents1About this GuideShanghai Anti-monopoly Compliance Guide for Undertakings (“this Guide” or the “Compliance Guide”) aims to help undertakings in Shanghai ensure compliance with the Anti-monopoly Law of the People’s Republic of China (the “AML”), become aware of, prevent and control anti-monopoly risks, and establish a law-abiding corporate image. This Guide also aims to stimulate the creativity of companies and enhance their competitiveness.This Guide is expected to create an interest in fair competition, optimize the market environment, support the implementation of competition policies, and improve the transparency of law enforcement in Shanghai, which will shape a unified, open and fair market system.This Guide is a non-regulatory document. It Array only provides information for the purpose ofgeneral guidance and does not constitute anylegal or other professional advice, nor anylegal statement in any jurisdictionsThis Guide is subject to the time limit, aslaws, regulations and regulatory documentsmay be updated from time to time.For any specific issue, please seek advicefrom professionals.This Guide can be used by industry associa-tions as a guiding reference for anti-monopolycompliance.12About the Anti-monopoly Law ofthe People's Republic of ChinaFair competition can inspire innovation, improve efficiency, and enable companies to provide better services and a wider range of choices at lower prices.In other words, efficiency and progress can be realized through fairer market compe-tition. As competition intensifies in both the domestic and global markets, compa-nies of all sizes should strive to improve efficiency as much as possible, rather than seek survival and development by anti-competitive means.The competition law system is a fundamental legal construct in a market economy. China has enacted the AML in order to maintain market order, improve the efficiency of business operations, and prevent conspiracy between undertakings or the abuseof dominant market positions.Under the AML, China’s competition law system also includes the Interim Provisions on the Review of Concentrations of Undertakings, the Interim Provisions on Prohibi-tion of Monopoly Agreements, and the Interim Provisions on Prohibiting Abuse of Dominant Market Positions.The AML and its supporting regulations and provisions have equal statutory power. Any undertaking who fails to fulfill the obligations under the AML or engages in conducts prohibited by the AML will be penalized by the anti-monopoly enforcement authority (the “AMEA”) unless their acts fall within specified exemptions. The maxi-mum fine for AML violation is 10% of the undertaking’s sales revenue of the previous year. A violating undertaking is also liable to civil litigation claims from other under-takings or customers.2Legal Liabilities3 Any undertaking who fails to comply with the AML or fails to prevent or control anti-monopoly risks will be subject to legal liabilities.Administrative liabilities under the AMLThe AMEA shall order them to cease doing so, confiscate their illegal gains, and impose a fine of 1% up to 10% of the total sales revenue (rather than sales revenue of relevant products) achieved in the previous year. Where a guild helps the achievement of a monopoly agreement by undertakings in its own trade, a fine of less than 500,000 yuan shall be imposed thereupon by the AMEA.The AMEA shall order them tocease doing so, to dispose ofshares or assets, transfer thebusiness or take othernecessary measures torestore the market condition within a time limit, and mayimpose a fine of less than500,000 yuan.Any undertaking who reaches a monopoly agreement, abuses his dominant market positions, or implements concentration that eliminates or restricts competition in violation of the AML, unless there is a valid reason for exemption, or refuses or hinders anti-monop-oly investigations, shall be investigated and penalized by the AMEA according to law.Any undertaking who engagesin monopolistic conducts andcauses any loss to othersshall assume civil liabilities.Any undertaking who refuses to cooperate with or hinders any anti-monopoly investiga-tion to the extent that his misconducts constitute a crime shall be prosecuted forcriminal liabilities.3The AMEA shall order them to make rectification, impose a fine of less than 20,000 yuan on individuals, and a fine of less than 200,000 yuan on entities.In serious cases, the AMEA may impose a fine of 20,000 yuan up to 100,000 yuan on individuals, and a fine of 200,000 yuan up to one million yuan on entities.Undertakings are encouraged to ensure their compliance with the AML, and will be appreciated for their pro-competition business conducts and their competitive corporate culture.Still, there is no universal set of anti-monopoly compliance strategies suitable for all undertakings. Undertakings are recommended to formulate and implement compliance measures that suit their own conditions, including their business size, financial standing, and main sources of risks.Undertakings are advised to improve their internal AML compliance system, formulate compliance policies, and conduct regular assessments via an internal department or external professional agency. Undertakings may consider building:How to Ensure Compliance4 A compliance culture: Integrating honesty, trustwor-thiness, compliance, and fair competition into the corpo-rate culture, and raising employees' awareness of competition and AML compli-ance.A training mechanism: Offering continuous and regular trainings to employ-ees to raise their awareness of prohibited acts and corresponding responses; Designing and implementing a more specific training program for employees on high-risk positions such as sales, procurement, sales network management, liaison with industry associations, and participation in industry, pricing and business decision making.A competition law compliance consultation mechanism: Including internal consulta-tion, external expert consulta-tion, and enforcement authority consultation.An audit mechanism: Conducting internal audits for major decisions and important agreements, and consulting internal legal counsellors, external lawyers, or other professional agen-cies on anti-monopoly risks. A risk disposal mechanism: Implementing proper control, timely mitigation, and appropriate solutions.A compliance commitment mechanism: Getting directors, executives, managers, and supervisors to personally commit to competition law compliance in written statements.A reporting mechanism: Reporting to the management and executives, covering detected risks and counter-measures.4Undertakings are advised to appoint a delegator to be responsible for AML compliance.Where possible, undertakings may consider setting up positions such as legal specialists or competition compliance officers, and hiring professionals to fill the positions. Small undertakings may consider picking a director, executive, manager, or supervisor to take charge of this function.At the same time, they are advised to clearly define the responsibilities of managers and competent depart-ments, and coordinate measures and resources to prevent and control anti-competitive risks. Undertakings may consider formulating appropriate incentives and punishment systems to ensure the implementation of compliance policies.Undertakings may consider seeking external professional support from law firms and economic analysts. Undertakings must ensure the consistency of compliance efforts, make corrections as necessary and improve their practices based on the effectiveness of implementation.5Identiﬁcation and Prevention of Monopolistic ConductsAlso called a “hard core cartel”, a horizontal monopoly agreement is equivalent to conspiracy or collusion. A horizontal monopoly agreement is a conduct which is strictly forbidden and severely punished in almost every country, and is also the most important AML risk faced by undertakings.All undertakings shall independently conduct sales and procurement and make independent decisions of relevant market behaviors.Monopoly agreement reached with actual or potential competitors (Horizontal Monopoly Agreements)65 Under the AML, “monopoly agreements” include agreements, decisions and other concerted conducts designed to eliminate or restrict competition.For this purpose, “agreements” refer to written or oral agreements by which undertakings express an anti-competitive consensus.“Decision” refers to the group consensus of undertakings which is executed by the group members. It is equivalent to an agreement reached by the members, considering the nature and consequences.“Concerted conducts” refer to coordinated and consistent conducts of undertakings who have not entered into a written or oral agreement or taken a clear consensus-based decision, but may take coordinated actions to restrict competition, including market behaviors that are consistent but cannot be reasonably explained, intentional contacts and information exchange.。

美国应对细菌耐药国家行动计划

NAT IONA L AC T ION PL A N FOR COM BAT I NG A N T IBIOT IC-R ESISTA N TBAC TER I AM A R C H2015Table of ContentsExecutive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Goals1 .Slow the Emergence of Resistant Bacteria and Prevent the Spread of ResistantInfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112 .Strengthen National One-Health Surveillance Efforts to Combat Resistance . . . . .243 .Advance Development and Use of Rapid and Innovative Diagnostic Tests forIdentification and Characterization of Resistant Bacteria . . . . . . . . . . . . .364 .Accelerate Basic and Applied Research and Development for New Antibiotics,Other Therapeutics, and Vaccines . . . . . . . . . . . . . . . . . . . . . .405 .Improve International Collaboration and Capacities for Antibiotic-resistancePrevention, Surveillance, Control, and Antibiotic Research and Development . . . . .49 Tables1 .National Targets for Combating Antibiotic-Resistant Bacteria . . . . . . . . . . .62 .Goals and Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . .93 .Antibiotic-Resistant Threats in the United States . . . . . . . . . . . . . . . .60 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Executive SummaryAntibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world . Today, however, the emergence of drug resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent . The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone .The National Action Plan for Combating Antibiotic-resistant Bacteria provides a roadmap to guide the Nation in rising to this challenge . Developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria—issued by President Barack Obama on September 18, 2014—the National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST) . Although its primary purpose is to guide activities by the U .S .Government, the National Action Plan is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug-resistant threats that affect people in the U .S .and around the world . Implementation of the National Action Plan will also support World Health Assembly resolution 67 .25 (Antimicrobial Resistance), which urges countries to take urgent action at the national, regional, and local levels to combat resistance .The goals of the National Action Plan include:1. Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections .2. Strengthen National One-Health Surveillance Efforts to Combat Resistance .3. Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification andCharacterization of Resistant Bacteria .4. Accelerate Basic and Applied Research and Development for New Antibiotics, OtherTherapeutics, and Vaccines .5. Improve International Collaboration and Capacities for Antibiotic-resistance Prevention,Surveillance, Control, and Antibiotic Research and Development .By 2020, implementation of the National Action Plan will lead to major reductions in the incidence of urgent and serious threats, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile (see Table 1) . The National Action Plan will also result in improved antibiotic stewardship in healthcare settings, prevention of the spread of drug-resistant threats, elimination of the use of medically-important antibiotics for growth promotion in food animals, and expanded surveillance for drug-resistant bacteria in humans and animals .Other significant outcomes include creation of a regional public health laboratory network, establishment of a specimen repository and sequence database that can be accessed by industrial and academic research-ers, development of new diagnostic tests through a national challenge, and development of two or moreNAT I ONAL ACT I ON P LAN FOR COMBAT I NG ANT I BI OT I C-RESISTANT BACT ERIA antibiotic drug candidates or non-traditional therapeutics for treatment of human disease . In addition, the effort to combat resistant bacteria will become an international priority for global health security . Progress towards achieving these outcomes will be monitored by the U .S .Government Task Force that developed the National Action Plan. The Task Force, which is co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services, includes representatives from the Departments of State, Justice, Veterans Affairs, and Homeland Security, as well as the Environmental Protection Agency, the United States Agency for International Development, the Office of Management and Budget, the Domestic Policy Council, the National Security Council, the Office of Science and Technology Policy, and the National Science Foundation . Additionally, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, created by Executive Order 13676, will provide advice, information, and recommendations to the Secretary of Health and Human Services regarding the National Action Plan’s programs and policies and their impact on the threat .Implementation of the objectives and activities in the National Action Plan requires sustained, coordi-nated, and complementary efforts of individuals and groups around the world, including healthcare providers, healthcare leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients . All of us who depend on antibiotics must join in a common effort to detect, stop, and prevent the emergence and spread of resistant bacteria .IntroductionVision: The United States will work domestically and internationally to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria byimplementing measures to mitigate the emergence and spread of antibiotic-resistance and ensuring the continued availability of therapeutics for the treatment of bacterial infections. Antibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world . Today, however, the emergence of drug resistance in bacteria is reversing the gains of the past eighty years, with many important drug choices for the treatment of bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent . The Centers for Disease Control and Prevention (CDC) estimates that each year at least two million illnesses and 23,000 deaths are caused by drug-resistant bacteria in the United States alone .The loss of antibiotics that kill or inhibit the growth of bacteria means that we can no longer take for granted quick and reliable treatment of rare or common bacterial infections, including bacterial pneu-monias, foodborne illnesses, and healthcare-associated infections . As more strains of bacteria become resistant to an ever larger number of antibiotics, we will also lose the benefits of a range of modern medi-cal procedures—from hip replacements to organ transplants—whose safety depends on our ability to treat bacterial infections that may arise as post-surgical complications . Moreover, antibiotic-resistance also threatens animal health, agriculture, and the economy .The National Action Plan for Combating Antibiotic-resistant Bacteria provides a roadmap to guide the Nation in rising to this challenge . The National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology . Although its primary purpose is to guide activities by the U .S .Government, the National Action Plan is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug-resistant threats (Table 3) that affect people in the U .S .and around the world .Goals of the National Action PlanThe National Action Plan—informed by the guiding principles in Table 2—is organized around five goals for collaborative action by the U .S .Government, in partnership with foreign governments, individuals, and organizations aiming to strengthen healthcare, public health, veterinary medicine, agriculture, food safety, and research and manufacturing . Aggressive action will move the nation towards major reductions in the incidence of urgent and serious drug-resistant threats (Table 3), including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile.•Misuse and over-use of antibiotics in healthcare and food production continue to hasten the development of bacterial drug resistance, leading to loss of efficacy of existing antibiotics .•Detecting and controlling antibiotic-resistance requires the adoption of a “One-Health” approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment .•Implementation of evidence-based infection control practices can prevent the spread of resistant pathogens .•Interventions are necessary to accelerate private sector investment in the development of therapeutics to treat bacterial infections because current private sector interest in antibiotic development is limited .•Researchers can use innovations and new technologies—including whole genome sequencing, metagenomics, and bioinformatic approaches—to develop next-generation tools to strengthen human and animal health, including:−Point-of-need diagnostic tests to distinguish rapidly between bacterial and viral infections as well as identify bacterial drug susceptibilities;−New antibiotics and other therapies that provide much needed treatment options for those infected with resistant bacterial strains; and−Antibiotic resistance is a global health problem that requires international attention and collaboration, because bacteria do not recognize borders .1. The TB activities identified in the NAP are included as they represent critical near-term public health activities that will support progress to reduce the burden of drug-resistant TB in the U .S . Additional domestic and global activitiesto address drug-resistant TB will be provided in a companion action plan specific to TB and will be submitted to the President no later than September, 2015 . The companion action plan will build on recommendations of the Federal TB Task Force (http://www .cdc .gov/mmwr/pdf/rr/rr5803 .pdf) as well the work of the interagency USG TB working group . Those goals include:GOAL 1: Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections. Judicious use of antibiotics in healthcare and agricultural settings is essentialto slow the emergence of resistance and extend the useful lifetime of effective antibiotics .Antibiotics are a precious resource, and preserving their usefulness will require cooperationand engagement by healthcare providers, healthcare leaders, pharmaceutical companies,veterinarians, the agricultural industry, and patients . Goal 1 activities include the optimaluse of vaccines to prevent infections, implementation of healthcare policies and antibioticstewardship programs that improve patient outcomes, and efforts to minimize the develop-ment of resistance by ensuring that each patient receives the right antibiotic at the right timeat the right dose for the right duration. Prevention of resistance also requires rapid detectionand control of outbreaks and regional efforts to control transmission across community andhealthcare settings .GOAL 2: Strengthen National One-Health Surveillance Efforts to Combat Resistance. Improved detection and control of drug-resistant organisms will be achieved through an integrated,“One-Health” approach that includes the enhancement and integration of data from surveil-lance systems that monitor human pathogens—including the National Healthcare SafetyNetwork (NHSN), the Emerging Infections Program (EIP), and the National AntimicrobialResistance Monitoring System (NARMS)—with data from surveillance systems that monitoranimal pathogens—including the National Animal Health Monitoring System (NAHMS),the National Animal Health Laboratory Network (NAHLN), and the Veterinary LaboratoryInvestigation and Response Network (Vet-LIRN) . Goal 2 activities include creation of aregional public health laboratory network that provides a standardized platform for resistancetesting and advanced capacity for genetic characterization of bacteria (e .g ., through wholegenome sequencing) . Goal 2 activities will also enhance monitoring of antibiotic sales, usage,resistance, and management practices at multiple points along in the food-production chain,from farms to processing plants to supermarkets .GOAL 3: Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria. Improved diagnostics fordetection of resistant bacteria and characterization of resistance patterns will help healthcareproviders make optimal treatment decisions and assist public health officials in taking actionto prevent and control disease . Improved diagnostics will also help decrease unnecessaryor inappropriate use of antibiotics . Goal 3 activities will accelerate the development of newdiagnostics and expand their availability and use to improve treatment, enhance infectioncontrol, and achieve faster response to infections and outbreaks caused by resistant bacteriain hospitals and in the community .GOAL 4: Accelerate Basic and Applied Research and Development for New Antibiotics, Other Therapeutics, and Vaccines. Despite the urgent need for new antibiotics, the number ofproducts in the drug-development pipeline is small and commercial interest remains limited .The advancement of drug development—as well as non-traditional therapeutics and vac-cines—will require intensified efforts to boost scientific research, attract private investment,and facilitate clinical trials of new drug candidates . Goal 4 activities will help accomplish theseobjectives by supporting basic and applied research, providing researchers with scientificservices (e .g ., specimens, sequence data, and regulatory guidance), and fostering public-private partnerships that strengthen the clinical trials infrastructure and reduce the risks,uncertainty, and obstacles faced by companies who are developing new antibiotics and/orother therapeutics and vaccines that can impact the use of antibiotics and the developmentof resistance .GOAL 5: Improve International Collaboration and Capacities for Antibiotic-resistance Prevention, Surveillance, Control, and Antibiotic Research and Development. Antibioticresistance is a worldwide problem that cannot be addressed by one nation in isolation . Goal5 activities include working with foreign ministries of health and agriculture, the World HealthOrganization (WHO), the Food and Agriculture Organization (FAO), the World Organizationfor Animal Health (OIE), and other multinational organizations to enhance global capacity todetect, analyze, and report antibiotic use and resistance, create incentives for the develop-ment of therapeutics and diagnostics, and strengthen global efforts to prevent and controlthe emergence and spread of antibiotic-resistance . To advance these objectives, U .S .agencieswill support development of a WHO Global Action Plan on Antimicrobial Resistance, enhanceinternational collaborations including cooperation under the European Union-United StatesTrans-Atlantic Task Force on Antimicrobial Resistance (TATFAR), and mobilize global healthresources through the Global Health Security Agenda .Development of the National Action PlanThe National Action Plan was developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria (Appendix 2), which was issued by President Barack Obama on September 18, 2014 in conjunction with the National Strategy for Combating Antibiotic-Resistant Bacteria.The Executive Order calls for a U .S .Government Task Force to create a five-year action plan that lays out steps and milestones for achieving the Strategy’s goals and objectives (Table 2) and addressing the PCAST recommendations . The Task Force, which is co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services, includes representatives from the Department of State, the Department of Justice, the Department of Veterans Affairs, the Department of Homeland Security, the Environmental Protection Agency, the United States Agency for International Development, the Office of Management and Budget, the Domestic Policy Council, the National Security Council staff, the Office of Science and Technology Policy, and the National Science Foundation .Development of the National Action Plan also supports World Health Assembly (WHA) resolution 67 .25 (Antimicrobial Resistance), which was endorsed in May 2014 and urges countries to develop and finance national plans and strategies and take urgent action at the national, regional, and local levels to combat resistance . The resolution urges WHA Member States to develop practical and feasible approaches to, among other actions, extend the lifespan of drugs, strengthen pharmaceutical management systems and laboratory infrastructure, develop effective surveillance systems, and encourage the development of new diagnostics, drugs, and treatment options .These recommendations are intended to inform the policy development process, and are not intended as a budget document . The commitment of resources to support these activities will be determined through the usual Executive Branch budget processes . Implementation of some of the actions in this report will require additional resources and these resources could be new or redirected from lower-priority Agency activities .Monitoring and EvaluationThe Task Force created under Executive Order 13676 is charged with providing the President with annual updates on Federal Government actions to combat antibiotic resistance, including progress made in implementing the National Action Plan, plans for addressing obstacles and challenges, and recommenda-tions for new or modified actions . The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria will provide advice, information, and recommendations to the Secretary of Health and Human Services regarding the programs and policies developed in the National Action Plan .Partnerships and ImplementationImplementation of the National Action Plan will require the sustained, coordinated, and complemen-tary efforts of individuals and groups around the world, including public and private sector partners, healthcare providers, healthcare leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients . All of us who depend on antibiotics must join in a common effort to detect, stop, and prevent the emergence and spread of resistant bacteria .NAT I ONAL ACT I ON P LAN FOR COMBAT I NG ANT I BI OT I C-RESISTANT BACT ERIAGOAL 1. Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant InfectionsJudicious use of antibiotics in healthcare and agricultural settings is essential to slow the emergence of resistance and extend the useful lifetime of effective antibiotics . Antibiotics are a precious resource, and preserving their usefulness will require cooperation and engagement by healthcare providers, healthcare leaders, pharmaceutical companies, veterinarians, the agricultural industry, and patients . Effective dissemination of information to the public is critical . Prevention of resistance also requires rapid detection and control of infections and outbreaks (see also Goal 2) and regional efforts to control transmission across community and healthcare settings .Goal 1 includes activities to foster antibiotic stewardship by improving prescribing practices across all healthcare settings, prevent the spread of drug-resistant threats in healthcare facilities and communities, and reduce and eventually eliminate the use of medically-important antibiotics for growth promotion in animals .By 2020, significant outcomes of Goal 1 will include:•Establishment of antibiotic stewardship programs in all acute care hospitals and improved antibiotic stewardship across all healthcare settings .•Reduction of inappropriate antibiotic use by 50% in outpatient settings and by 20% in inpatient settings .•Establishment of State Antibiotic Resistance (AR) Prevention (Protect) Programs in all 50 states to monitor regionally important multidrug resistant organisms and provide feedback and technical assistance to healthcare facilities .Actions taken to achieve Goal 1 will fulfill:• Executive Order 13676, Sections 5 and 7:−Improved Antibiotic Stewardship−Preventing and Responding to Infections and Outbreaks with Antibiotic-Resistant Organisms• Provisions in PCAST Recommendations #2, #6, and #7:−Effective Surveillance & Response for Antibiotic-resistance−Improving Stewardship of Existing Antibiotics in Health Care−Limit the Use of Antibiotics in Animal Agriculture•Elimination of the use of medically-important antibiotics for growth promotion in food-pro-ducing animals .•Requirement of veterinary oversight for use of medically-important antibiotics in the feed or water of food-producing animals .1.1 Implement public health programs and reporting policies that advanceantibiotic resistance prevention and foster antibiotic stewardship inhealthcare settings and the community.Perhaps the single most important action to slow the development and spread of antibiotic-resistant infections is to change the way antibiotics are used . Antibiotics are overprescribed in both human and animal settings, which makes everyone less safe . Investments in this area will be used to develop education and outreach programs to clarify and strengthen responsible, appropriate use of antibiotics in humans and animals . Efforts in this area will help greatly in slowing down the spread of resistant bacteria . This commitment to always use antibiotics appropriately and safely—to use the right antibiotic at the right time at the right dose for the right duration—is known as antibiotic stewardship.Sub-Objective 1.1.1A: Strengthen antibiotic stewardship in inpatient, outpatient, and long-term care settings by expanding existing programs, developing new ones, and monitoring progress and efficacy .The establishment and expansion of antibiotic stewardship programs will improve patient outcomes and minimize the development of resistance by ensuring judicious use of antibiotics .Milestones for provision of educational materials to enhance antibiotic stewardship in outpatient settings are provided under Sub-Objective 1 .1 .1B .MilestonesWithin one year:•The Departments of Health and Human Services (HHS), Defense (DOD), and Veterans Affairs (VA) will review existing regulations and propose new ones, as needed, requiring hospitals, ambulatory surgery centers, dialysis facilities, and other inpatient facilities to implement robust antibiotic stewardship programs that align with the CDC Core Elements. HHS, DOD, and VA will also work together to optimize standardization of stewardship programs and activities, including monitoring activities and reporting criteria .•The National Healthcare Safety Network (NHSN) will begin tracking the number of healthcare facilities with stewardship policies and programs in place .•DOD will establish a multidisciplinary group, under the purview of the Assistant Secretary of Defense for Health Affairs, to support and coordinate stewardship activities across DOD .Within three years:•All hospitals that participate in Medicare and Medicaid programs must comply with Conditions of Participation (COP) . The Centers for Medicare & Medicaid Services (CMS) will issue new COPs or revise current COP Interpretive Guidelines to advance compliance with recommendations in CDC’s Core Elements of Hospital Antibiotic Stewardship Programs. HHS, DOD, and VA will also implement policies that:−Encourage implementation of antibiotic stewardship programs as a condition for receiving Federal grants for health care delivery (e .g ., in community healthcare centers) .−Require health facilities operated by the U .S . Government to develop and implement antibiotic stewardship programs and participate in NHSN reporting (see Objective 2 .2) .•All acute care hospitals governed by the CMS COP will implement antibiotic stewardship pro-grams . CMS will expand COP requirements to apply to long-term acute care hospitals, other post-acute facilities, ambulatory surgery centers, and dialysis centers .•CMS will revise existing Interpretive Guidelines (IGs), as needed, to include antimicrobial steward-ship improvements . For example, IGs on Quality Assurance and Performance Improvement for hospitals may incorporate antibiotic-stewardship performance measures developed by the CDC, the Agency for Healthcare Research and Quality (AHRQ), or other professional organizations .•Training webinars for CMS surveyors will be updated to include information on antibiotic utilization in nursing homes, in accordance with existing IGs in the Infection Control Nursing Home regulations .•CDC, CMS, AHRQ, and other partners will issue guidance on antibiotic stewardship and best practices for ambulatory surgery centers, dialysis centers, nursing homes and other long-term care facilities, doctors’ offices and other outpatient settings, pharmacies, emergency depart-ments, and medical departments at correctional facilities .•At least 25 States, the District of Columbia, and Puerto Rico will establish or enhance antibiotic stewardship activities in inpatient healthcare delivery settings, in accordance with the CDC Core Elements . CDC will support these efforts via State AR Prevention (Protect) Programs for Healthcare (“AR Protect Programs”; see also Sub-Objective 1 .1 .2) .Within five years:•DOD will support antibiotic stewardship programs and interventions critical for maintaining quality health care throughout the Military Healthcare System (MHS) .•CDC will work with select hospital systems to expand antibiotic use reporting and steward-ship implementation, and will partner with nursing organizations to develop and implement stewardship programs and interventions in a set of nursing homes .•All states will establish or enhance antibiotic stewardship activities in healthcare delivery settings .Sub-Objective 1.1.1B: Strengthen educational programs that inform physicians, veterinari-ans, members of the agricultural industry, and the public about good antibiotic stewardship .Educational programs that promote good antibiotic stewardship in healthcare settings include:•Get Smart: Know When Antibiotics Work . Many antibiotics prescribed in doctors’ offices, clinics, and other outpatient settings are not needed . This program focuses on appropriate antibiotic prescribing and use for common illnesses in children and adults .•Get Smart for Healthcare. Many patients in hospitals, nursing homes, and other healthcare facili-ties receive antibiotics to fight infections, but these drugs are often prescribed incorrectly . This program helps clinicians prescribe the right drugs for the right patients at the right doses and times . The United States Department of Agriculture (USDA), CDC, and the Food and Drug Administration (FDA) will also continue to work with partners in the agriculture industry to advance appropriate use of antibiotics in food animals and promote collaborations among partners in medicine, veterinary medicine, and public health .Additional milestones for provision of educational materials to enhance antibiotic stewardship in agri-cultural settings are provided under Sub-Objectives 1 .2 .3 and 1 .3 .1 .MilestonesWithin one year:•CDC and VA will apply lessons learned from the CDC and VA pilot project to provide clinicians with support for making prescribing decisions based on judicious use of antibiotics and will submit a manuscript for publication describing initial research findings from this effort . Within three years:•CDC will support public health departments in establishing statewide programs for antibiotic stewardship and appropriate antibiotic use . These programs will identify healthcare facilities with high antibiotic-prescribing rates and use lessons learned from the CDC and VA pilot project (see above) and other best practices to improve antibiotic prescribing in these facilities . The success of these efforts will be assessed by measuring changes in prescribing rates and in clini-cians’ understanding of antibiotic stewardship activities and programs .•CDC will provide technical assistance to Federal facilities (e .g ., those operated by DOD, the VA, and the Indian Health Service) and other large health systems in scaling up implementation and assessment of interventions to improve outpatient antibiotic prescribing, extending effective interventions to long-term care settings, and ensuring long-term sustainability of antibiotic stewardship efforts .•DOD will initiate the planning and approval process to modify clinical decision-support interven-tions in DOD facilities in targeted regions .•CDC, CMS, and partners will propose expanded quality measures for antibiotic prescribing .。

待签合同的一致性法规

待签合同的一致性法规英文回答：Consistency regulations for pending contracts require that all terms and conditions outlined in the contract are clear, unambiguous, and in agreement with each other. This means that there should be no conflicting or contradictory provisions within the contract. The purpose of these regulations is to ensure that the parties involved in the contract have a clear understanding of their rights and obligations.For example, let's say I am in the process of signing a contract to purchase a property. The contract states that the seller is responsible for all repairs and maintenance of the property. However, in another section of the contract, it states that the buyer is responsible for any repairs needed within the first year of ownership. These provisions are inconsistent and contradictory, creating confusion and potential disputes between the parties.To avoid such inconsistencies, it is important to carefully review and analyze the contract before signing. This includes checking for any conflicting provisions, ensuring that all terms and conditions are in agreement, and seeking clarification or amendment if necessary. In some cases, it may be necessary to consult with legal professionals to ensure compliance with consistency regulations.中文回答：待签合同的一致性法规要求合同中的所有条款和条件都清晰、明确，并且彼此之间保持一致。

自由贸易试验区外商投资准入特别管理措施(负面清单) 中英对照版本

Notice of the General Office of the State Council on Issuing the Special Management Measures (Negative List) for Foreign Investment Access in Pilot Free Trade Zones[Effective] 国务院办公厅关于印发自由贸易试验区外商投资准入特别管理措施(负面清单)的通知[现行有效]Issuing authority:General Office of the State Council Document Number:No. 23 [2015] of the General Office of the State CouncilDate issued:04-08-2015 Level of Authority:Regulatory Documents of the State CouncilArea of law:Foreign Economy and Trade,Reform and Opening-upNotice of the General Office of the State Council on Issuing the Special Management Measures (Negative List) for Foreign Investment Access in Pilot Free Trade Zones 国务院办公厅关于印发自由贸易试验区外商投资准入特别管理措施（负面清单）的通知(No. 23 [2015] of the General Office of the State Council) （国办发〔2015〕23号）The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council; and all institutions directly under the State Council: 各省、自治区、直辖市人民政府，国务院各部委、各直属机构：The Special Management Measures (Negative List) for Foreign Investment Access in Pilot Free Trade Zones has been approved by the State Council, and is hereby issued to you for your conscientious implementation. You shall, in a timely manner, report all significant issue, if any, encountered in the implementation thereof to the State Council for instructions. 《自由贸易试验区外商投资准入特别管理措施（负面清单）》已经国务院同意，现印发给你们，请认真执行。

（关于外国投资者并购境内企业的规定）1

Certain Recent Entrepreneurial Responses to China’s Mergers &Acquisitions RulesArticle Contributed by:Simon Luk, Winston & Strawn LLPUntil the arrival of the worldwide financial crisis in late 2008, private equity in the People’s Republic of China (PRC) grew tremendously in recent years. The growth was spurred by offshore funds seeking to take advantage of the entrepreneurial talents of the private Chinese business community and Chinese entrepreneurs who wished to access foreign capital markets and re-invest in China under the more favorable guise of a foreign entity.The PRC regulatory authorities, including the Ministry of Commerce (MOFCOM) and the State Administration of Foreign Exchange (SAFE) became concerned about the loss of tax revenue, control of sensitive assets by offshore persons, and the redomiciling of assets, and decided to tighten regulatory controls on PRC entrepreneurs, and the venture capital and private equity community. Consequently, the PRC government issued stricter regulations imposing approval requirements on foreign investments, including the Provisions on the Merger and Acquisition of Domestic Enterprises by Foreign Investors (关于外国投资者并购境内企业的规定)1, generally known as the PRC M&A Rules (the Rules) and several related regulations and guidelines.As a result, the once-prevalent “round trip” investment, which involved an offshore company owning a domestic business on mainland China, was largely curtailed. Chinese entrepreneurs and their advisors, in turn, responded to this increased regulatory oversight by employing certain investment vehicles aimed at avoiding the harsher effects of the new government rules, including structures popularly known as the “slow walk” arrangement and the “variable interest entity.” Both structures have triggered some debate among Chinese lawyers2 and entail some degree of risk for those who have resorted to them, as the following analysis will articulate.The 2006 PRC M&A RulesIt has been more than two years since MOFCOM, along with five other ministries—the State-owned Assets Supervision and Administration Commission of the State Council, State Administration of Taxation, State Administration for Industry and Commerce, China Securities Regulatory Commission, and SAFE—jointly issued the Rules. The Rules became effective on 8 September 2006. In brief, the Rules provide that if a Chinese domestic company merges with an offshore company established by the Chinese resident who controls such domestic company before the merger, an application must be made to MOFCOM for approval.One of the principal reasons for the implementation of the Rules was in response to the use of round-trip investment structures used by Chinese domestic businesses to take advantage of tax and other incentives that the PRC government has granted to non-Chinese businesses to stimulate foreign investment. In a round-trip investment structure, a Chinese entrepreneur would acquire his own domestic assets or businesses through a special purpose vehicle incorporated outside of China. By incorporating an offshore company and structuring it to own a Chinese domestic business, the Chinese entrepreneur could turn domestic assets and businesses into foreign-owned assets and businesses, entitling the entrepreneur to tax benefits available only to foreign investors. Although tax benefits were less of a motivating factor with the unification of the domestic and foreign tax law regimes, an important advantage of round-trip investment for Chinese entrepreneurs was that any subsequent change of ownership of an offshore holding company would no longer be subject to the approval of the Chinese authorities. Therefore, an offshore holding structure or “red-chip redomicile” provided more flexibility for Chinese entrepreneurs looking to attract foreign investment, since Chinese regulatory approval would not be necessary before an investment in, or purchase of, an offshore holding company. Foreign investors are generally more comfortable with investing in an offshore company incorporated in a tax haven because of the safety and flexibility such jurisdictions offer.© Bloomberg Finance L.P. 2009. Originally published by Bloomberg Finance L.P. Reprinted by permission.The Rules expressly require that parties to a merger or acquisition transaction involving Chinese companies and assets specify if the parties are associated with each other. If there are two parties that have the same de facto controller, the relevant parties must disclose the identity of the de facto controller to the approving authority and specify (1) the purposes of the transaction; and (2) whether the relevant valuation of the subject matter of the transaction represents a fair market value. The parties are prohibited to avoid this requirement by way of trust, nominee holding or other method. Since the enactment of the Rules, round-trip investment activities have been significantly curbed due to the difficulty in obtaining approvals. Accordingly, Chinese entrepreneurs and foreign investors have responded in a number of ingenious ways.Market Responses to the RulesIn response to the Rules, some Chinese and foreign market participants have devised new transactional structures aimed at avoiding the reporting requirements. Of particular interest are the “slow walk” arrangement (SWA) and the variable interest entity structure (VIE structure).“Slow Walk” Arrangement: Under a SWA, the owner of a PRC domestic business converts the domestic business to a foreign invested enterprise, usually a wholly foreign-owned enterprise, by selling the business to a special purpose vehicle owned by a third party. The special purpose vehicle is usually established in the British Virgin Islands or in Hong Kong. See Diagram I.Diagram IThe original owner (OO) is invariably the chief executive officer and chairman of a Chinese domestic enterprise before the sale to the special purpose vehicle. Because the OO is deemed key to the business, it is essential for the third party or the new owner to retain the service of the OO for the continued development of the business. As such, the new owner will enter into an earn-in agreement with the OO. Under the earn-in agreement, the new owner will, subject to satisfaction of certain conditions, grant a call option to the OO to purchase a controlling interest, usually over 50 percent, in the special purpose vehicle or its holding company which holds the original domestic business, over a period of time and in stages. The exercise price of the option is generally low, and very often the same as the par value of the shares.The conditions under which the call option may be exercised are usually linked to the entry of a binding employment agreement by the OO and/or attainment of certain profit levels by the group. In general, complying with the conditions will not be difficult. The option will have an exercise period similar to the term of the employment agreement with the OO. Such period may extend to as long as five years. Over such prolonged period, the OO will exercise the call option to require the new owner to gradually transfer the ownership of the business back to the OO. This is where the name “slow walk arrangement” originates. To secure the interest of the OO, the shares subject to the call option may be placed with a custodian upon signing of the earn-in agreement. This arrangement is structured as an incentive program for the key personnel. Therefore, in the application to the relevant Chinese authority to convert the domestic Chinese enterprise to a foreign invested enterprise, the OO is not regarded as being associated with the acquisition of the special purpose vehicle or the new owner. Some Chinese lawyers have taken the position that this arrangement will not be classified as a round-trip investment.It appears that no transaction adopting the SWA structure has ever been submitted to the Chinese authorities for clearance and no guidelines or rulings in respect of the SWA have been issued. Hence, the SWA does not seem to have been tested with the Chinese authorities. Because the Rules are worded very broadly and generally, the SWA may be deemed by MOFCOM as an arrangement made to avoid the application of the Rules.Besides the regulatory risk, the SWA is not hassle-free. With the controlling interest of the business held by a third party for a prolonged period, there is no guarantee that there will not be any disputes between the new owner and the OO over the direction, timing and valuation of fund raising exercises involving the business. As an example, the new owner’s compensation for participating in the SWA may be tied to a successful going public transaction, often accomplished via a reverse takeover of a listed shell company in the US over-the counter market. Particularly in light of the continuing financial crisis, the new owner may be motivated to complete a reverse takeover at the current low valuation over the objections of the OO, who would want to wait for a higher valuation. Disputes and lawsuits over the legality of the SWA may result. This may also pose potential management instability, which endangers the development of the business. The SWA has been described in SEC filings for a number of Chinese businesses that have raised funds outside China.Variable Interest Entity Structure: The VIE structure was in use even before the Rules became effective. It has been and still is widely used in businesses involving internet portals and other media related media in China, which prohibits direct ownership of such businesses by foreigners. Examples include Sina Corporation, Baidu, Inc. and Inc. See Diagram II.Diagram IIUnder a VIE structure, a domestic Chinese business is controlled, through various contractual arrangements, by a special purpose vehicle or an offshore entity. The OO of the domestic Chinese business becomes the beneficial owner by forming an offshore special purpose vehicle and simultaneously entering into a sale and purchase agreement with a Chinese resident for the sale of the domestic Chinese business. The Chinese resident would then sell the interest in the domestic Chinese enterprise to an independent third party, who must be a Chinese resident and would then become the legal owner. At the same time, the OO will enter into various contractual arrangements with the legal owner, which will normally include a technical service or support agreement to pay all or nearly all of the profits of the domestic Chinese enterprise in the form of service or support fees to the special purposes vehicle. As security for this arrangement, a loan agreement, share pledge and an option agreement will be prepared and executed. Under the loan agreement, the OO will advance to the legal owner sufficient funds to acquire the domestic enterprise from the OO. In return the legal owner will pledge the equity interest of the domestic Chinese enterprise in favor of the OO. The legal owner will also grant an option to the OO or its offshore vehicle to acquire the interest in the domestic Chinese enterprise. Under the contractual arrangements, the offshore entity will have all or nearly all of the profits and de facto control over the domestic Chinese enterprise for the benefit of the shareholders of the special purpose vehicle, which will include institutional investors.There is no need to make an application to MOFCOM for approval because a VIE structure only involves a transfer of the shares in a domestic Chinese enterprise between Chinese residents and there is no round-trip investment. The issue of round-trip investment is thereby avoided, at least formally. As with the SWA, there is no certainty that the VIE structure comports with the Rules. Also, the VIE structure suffers from the inability to transfer the assets and liabilities of the Chinese domestic enterprise to the special purpose vehicle, which will make listing in a foreign market difficult if not impossible. Finally, under international and U.S. generally accepted accounting principles, profits of the domestic Chinese enterprise are not included in profits of the special purpose vehicle unless the special purpose vehicle can demonstrate that it controls the Chinese enterprise through management or otherwise3.Despite these drawbacks, the VIE structure has been used in a number of recent fund raisings for expansion capital by Chinese companies seeking a listing or already listed in the U.S. The responses from institutional investors were encouraging until the arrival of the recent financialcrisis. The VIE structure has been used by Chinese companies engaged in all industries, including software, traditional industrial manufacturing, and natural resources mining.The Chinese government is keeping a close eye on the development of its economy, especially in the aftermath of the global financial crisis, to maintain a strict control regime. The Rules are an indication of its determination to assert control over what they regard as domestic Chinese assets. The Chinese government may impose tighter control over M&A activities involving Chinese entrepreneurs in order to preserve stability in both its foreign exchange policy and national capital account. Investors investing or planning to invest in structures similar to the ones described above should take into account the regulatory risks involved.Simon Luk, a partner in the firm’s Hong Kong office, is chairman of Winston & Strawn’s Asia practice. His practice focuses on international corporate securities. Mr. Luk represents multinational corporations in cross-border mergers and acquisitions, U.S. capital market fund raising, compliance with regulations of the Securities and Exchange Commission, and the acquisition of assets and brand names. Mr. Luk serves as honorary legal adviser to the Chamber of Listed Hong Kong Companies, the Hong Kong Electronics Association, the Toy Manufacturers Association of Hong Kong, the Hong Kong Electrical Appliances Manufacturers Association, the Hong Kong Young Industrialists Council, the Monte Jade Science and Technology Association of Hong Kong, the Hong Kong Brands Protection Alliance, and the Hong Kong Shandong Business Association.Email:****************.The views expressed herein are the author’s own and do not represent those of Bloomberg Finance L.P.1AvailableinSimplifiedChinese.See,forexample:/fortune/2006-08/10/content_4944032.htm.2There is no unified view as to the viability of such methods. For example, in his book titled “Venture Capital & Private Equity in China” (2008) published by Law Press China, Joseph Chan said on page 809 that “[a] literal reading of the definition of “mergers and acquisitions” under the [Rules] would appear to exclude from its scope of application certain contractual relationships that are commonly seen in venture investments in the restricted or prohibited sectors in China. Such contractual relationships are often referred to as the “Sina model” contracts…While there is no consensus yet on the applicability of the M&A Regulations to the Sina model contracts among industry players…It is unclear whether MOFCOM will broaden the scope of the M&A Regulations to cover the varied forms of the Sina model contracts.”3“Consolidation of Variable Interest Entities” - Financial Accounting Standards Board Interpretation No. 46R.。

ASA投稿要求

Table of Contents:I.General Editorial, Ethical and Legal Issues一般编辑、伦理、法律问题A.AuthorshipB.Group Authorship团体作者C.Group Collaborators合作者D.Copyright 版权E.Duplicate, Prior or Divided Publications重复的、优先的、分开的出版物F.Scientific Misconduct科学不端行为G.Human Studies: IRB Approval and Consent人体研究H.Animal Studies: Animal Care Approval动物研究：动物伦理批准I.Conflicts of Interest利益冲突pliance with NIH and Other Research Funding AgencyAccessibility Requirements符合美国国立卫生研究院和其他研究资助机构的可达性要求K.Study Design Issues实验设计1.PreClinical Trials2.Surveys调查3.Observational Studies观察性研究4.Clinical Trials临床试验II.Types of Papers论文类型A.Original Investigations原始调查B.Clinical Concepts and Commentary (CCC) Articles临床概念和评论文章C.Review Articles review文章D.Special Articles特殊文章E.Correspondence对应F.Mind to MindG.Clinical Practice Guidelines 临床指南H.Images in Anesthesiology (IiA) 图像I.Other Items其他项目III.Manuscript PreparationA.General Arrangement Information on electronic documents电子文件一般资料整理B.Title Page标题页C.Abstract (when required) 摘要D.Body Text正文E.References参考文献F.Tables表G.Appendices附录H.Figure Legends图I.Figures图1.Color Images彩图2.Preparation of Electronic Figures3.Journal Cover Figures杂志封面彩图J.Manuscripts "In Press"K.Supplemental Digital Content补充数字内容L.Additional Information附加信息1.Units of Measurement测量单位2.Abbreviations缩写3.Drug Names and Equipment药品名称和设备4.Data Reporting and Statistics数据报告和统计5.Patient Identification患者识别M.Permissions权限nguage Editing Services语言编辑服务IV.Submission of Electronic Documents提交电子文件A.File Formats, Text文件格式，B.File Formats, Fonts文本文件格式，字体C.File Formats, Graphics and Images图像和图形D.File Sizes文件大小I.General Editorial, Legal and Ethical IssuesA.AuthorshipEach manuscript must have one "Corresponding Author." Anesthesiology follows the ICMJERecommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work inMedical Journals to define the criteria required for authorship. All authors must have participated in the design, execution, and/or analysis of the work presented, and attest to the accuracy andvalidity of the contents. All persons or organizations involved in the work must be listed asauthors or acknowledged. Manuscripts are received with the understanding that they have beenwritten by the authors; ghostwritten papers are unacceptable. See Cullen D: Ghostwriting inscientific anesthesia journals. Anesthesiology 1997; 87: 195-6..每个手稿都必须有相应的作者。

美国食品安全法律法规

?联邦肉类检查法?、?禽类食品检验法?、?蛋类产品检验法?规定农业部下属的食品平安检验局〔FSIS〕的职责主要是标准肉、禽、蛋类制品，确保销售给消费者的肉类、禽类和蛋类产品是符合卫生的、不掺假的，并进行正确的标记、标识和包装。肉类、禽类和蛋类产品只有在盖有美国农业部的检验合格标记后，才允许销售和运输。这3部法律还要求向美国出口肉类、禽类和蛋类产品的国家必须具有等同于美国检验工程的检验能力。这种等同性要求不仅仅针对各国的检验体系，而且也包括在该体系中生产的产品质量的等同性。
美国?联邦食品、药品和化装品法?主要内容目录
1.法律禁止行为和违禁行为的处分; 2.食品的定义与标准; 3.食品中有毒成分的法定剂量; 4.农产品中杀虫剂化学品的残留量; 5.药品和器械; 6.新药; 7.人用器械的分类
8.药品和器械生产者的注册; 9.药品和器械上市前的批准; 10.禁用的仪器设备; 11.关于控制将用于人类的器械的一般规那么; 12.新动物药; 13.用于罕见疾病或病痛药品的保护; 14.食品、药品、医用器械的进出口管理。
五、负责官员和其他官员的检疫职责 1、任何负责官员和医官，受部长的指派应根据
总医官规定的形式与间隔时间向总医官报告所在港口和地方的卫生状况。
2、海关和边防官员有职责协助实施检疫规章和条例，但无额外补贴，除确实和必要的旅费外。六、卫生单证七、对民航及民航飞机的检疫条例八、违反检疫法规的处分九、检疫官员宣誓
§1046. 蛋类的进口〔Imports〕
§1047. 检查效劳的拒绝和撤销；听证会；与企业相关的责任人；农业部最终决议；司法检查；其它不受影响的拒绝效劳条款
§1048. 违禁物品的行政扣留；扣留时间；解除；官方标志的去除〔Administrative detention of violative articles; duration; release; removal of official marks〕

中华人民共和国知识产权海关保护条例（英文版）

中华人民共和国知识产权海关保护条例（英文版）Regulation of the P. R. China on the customs protection of IP rightsPART ONE GENERAL PROVISIONSArticle 1 These Regulations are formulated in accordance with the PRC, Customs Law in order to implement customs protection of intellectual property rights, promote foreign economic trade and technological and cultural exchange, and safeguard social interests.Article 2 For the purposes of these Regulations, “customs pr otection of intellectual property rights” refers to the implementation of protection by customs of the exclusive rights to use a trademark, copyrights and the rights related thereto, and patent rights that are related to import and export goods and that are protected by PRC laws and administrative regulations (Intellectual Property Rights).Article 3 The State prohibits the import and export of goods that infringe upon Intellectual Property Rights.Customs shall implement protection of Intellectual Property Rights and exercise the relevant powers stipulated in the PRC, Customs Law in accordance with the provisions of relevant laws and these Regulations.Article 4 Owners of Intellectual Property Rights that request customs to implement protection of Intellectual Property Rights shall submit an application to customs for adoption of protective measures.Article 5 Consignees of import goods or their agents, and consignors of export goods or their agents shall truthfully declare to customs the details of Intellectual Property Rightsrelated to the import or export goods, and shall submit the relevant supporting documents.Article 6 When implementing protection of Intellectual Property Rights, customs shall maintain the confidentiality of the trade secrets of the related parties.PART TWO RECORD FILING OF INTELLECTUAL PROPERTY RIGHTSArticle 7 An owner of Intellectual Property Rights may apply to the General Administration of Customs for record filing of his Intellectual Property Rights according to the provisions hereof. To apply for record filing, an application form shall be submitted. An application form shall include the following particulars:1. the name or personal name, place of registration or nationality, etc. of the owner of the Intellectual Property Rights;2. the name, details and the relevant information of the Intellectual Property Rights;3. the details of the exercise of the Intellectual Property Rights license;4. the name, place of origin, customs at the point of entry/exit, importers and exporters, major characteristics, and prices, etc. of the goods of which the Intellectual Property Rights are lawfully exercised by the owner of Intellectual Property Rights; and5. the manufacturers, importers and exporters, customs at the point of entry/exit, major characteristics, and prices, etc. of goods that are known to have infringed upon Intellectual Property Rights.Where there are supporting documents for the contents of the application form specified in the preceding paragraph, the owner of Intellectual Property Rights shall attach the supportingdocuments.Article 8 The General Administration of Customs shall, within 30 working days of the date of receipt of all application documents, render a decision on whether to grant approval for record filing, and shall notify the applicant in writing. Where approval for record filing is not granted, the reasons therefore shall be stated.The General Administration of Customs shall not grant approval for record filing in any of the following circumstances:1. the application documents are incomplete or invalid;2. the applicant is not the owner of the Intellectual Property Rights; or3. the Intellectual Property Rights are no longer protected by laws or administrative regulations.Article 9 If customs discovers that an owner of Intellectual Property Rights that applies for record filing of Intellectual Property Rights has not provided the relevant details or documents truthfully, the General Administration of Customs may revoke its filed record.Article 10 A filed record for customs protection of Intellectual Property Rights shall be effective as of the date on which the General Administration of Customs grants approval for record filing, and shall be valid for 10 years.Where the Intellectual Property Rights are valid, the owner of the Intellectual Property Rights may, within six months prior to the expiration of the term of validity of the filed record for customs protection of Intellectual Property Rights, apply to the General Administration of Customs for an extension of the filed record. The term of validity of each extension of a filed record shall be 10 years.Where no application for extension has been made upon the expiration of the term of validity of a filed record for customs protection of Intellectual Property Rights, or the Intellectual Property Rights are no longer protected by laws or administrative regulations, the filed record for customs protection of Intellectual Property Rights shall immediately become void.Article 11 Where there is a change in the details of a filed record of Intellectual Property Rights, the owner of the Intellectual Property Rights shall, within 30 working days of the date on which the change occurs, carry out the amendment or cancellation procedures with the General Administration of Customs.Where the owner of the Intellectual Property Rights does not apply to the amendment or cancellation procedures in accordance with the preceding paragraph so as to seriously affect other’s lawful import or export and the Customs supervision according to law, the General Administration of Customs can remove the record upon the application of the stakeholders or take the initiative to do so.PART THREE APPLICATION FOR IMPOUNDMENT OF GOODS SUSPECTED OF INFRINGING UPON RIGHTS, AND THE HANDLING THEREOFArticle 12 Where an owner of Intellectual Property Rights discovers that goods suspected of infringing upon rights are about to be imported or exported, he may submit an application for impoundment of goods suspected of infringing upon rights to the customs of the place where the goods are to enter into, or exit from, China.Article 13 Where an owner of Intellectual Property Rights requests customs to impound goods suspected of infringingupon rights, he shall submit an application form and the relevant supporting documents, and shall provide evidence that is sufficient to prove that the infringement clearly exists.An application form shall include the following main particulars:1. the name or personal name, place of registration or nationality, etc. of the owner of the Intellectual Property Rights;2. the name, details and the relevant information of the Intellectual Property Rights;3. the names of the consignees and consignors of the goods suspected of infringing upon rights;4. the name and specifications, etc. of the goods suspected of infringing upon rights; and5. the port by which, the time at which and the means of transportation by which, the goods suspected of infringing upon rights may enter into, or exit from, China.Where the goods suspected of infringing upon rights are suspected of infringing upon Intellectual Property Rights that are filed for record, the application form shall also include the customs record number.Article 14 Where an owner of Intellectual Property Rights requests customs to impound goods suspected of infringing upon rights, he shall provide to customsa guarantee equal to the value of the goods for compensation of any loss that may be incurred by the consignee or the consignor due to improper application, and for payment of fees for the storage, custody and disposal, etc. of the goods after they are impounded by customs. Where an owner of Intellectual Property Rights pays the fees for storage and custody directly to the storage provider, such fees shall be deducted fromthe guarantee. The specific procedures shall be formulated by the General Administration of Customs.Article 15 Where an owner of Intellectual Property Rights that applies for impoundment of goods suspected of infringing upon rights satisfies the provisions of Article 13 hereof and provides a guarantee in accordance with Article 14 hereof, customs shall impound the goods suspected of infringing upon rights, notify the owner of Intellectual Property Rights in writing, and deliver a certificate of impoundment by customs to the consignee or consignor.Where an owner of Intellectual Property Rights that applies for impoundment of goods suspected of infringing upon rights does not satisfy the provisions of Article 13 hereof or has not provided a guarantee in accordance with Article 14 hereof, customs shall reject the application and notify the owner of Intellectual Property Rights in writing.Article 16 Where customs discovers import or export goods that are suspected of infringing upon Intellectual Property Rights that are filed for record, it shall notify the owner of the Intellectual Property Rights immediately in writing. Where, within three working days of the date of delivery of the notification, the owner of the Intellectual Property Rights submits an application according to Article 13 hereof and provides a guarantee according to Article 14 hereof, customs shall impound the goods suspected of infringing upon rights, notify the owner of the Intellectual Property Rights in writing, and deliver a certificate of impoundment by customs to the consignee or consignor. Where the owner of the Intellectual Property Rights fails to submit an application or provide a guarantee within the time limit, customs may not impound the goods.Article 17 An owner of Intellectual Property Rights and the consignee or consignor may inspect the relevant goods upon the approval of customs.Article 18 Where the consignee or consignor considers that his goods have not infringed upon the Intellectual Property Rights of the owner of Intellectual Property Rights, he shall submit a written explanation to customs and attach the relevant evidence.Article 19 Where a consignee or consignor of goods suspected of infringing upon patent rights considers that his import or export goods have not infringed upon patent rights, he may, after providing a guarantee equal to the value of the goods, request customs to release his goods. If the owner of Intellectual Property Rights fails to institute an action at a people’s court within a reasonable time period, customs shall return the guarantee.Article 20 If, after customs has discovered import or export goods suspected of infringing upon Intellectual Property Rights that are filed for record and has notified the owner of the Intellectual Property Rights, the owner of the Intellectual Property Rights requests customs to impound the goods suspected of infringing upon rights, customs shall, within 30 working days of the date of impoundment, investigate and confirm whether the impounded goods suspected of infringing upon rights have infringed upon Intellectual Property Rights. If it cannot confirm an infringement, it shall notify the owner of the Intellectual Property Rights immediately in writing.Article 21 Where customs conducts an investigation into the impounded goods suspected of infringing upon rights and requests the assistance of the department in charge ofIntellectual Property Rights, the relevant department in charge of Intellectual Property Rights shall provide assistance.Where the department in charge of Intellectual Property Rights requests customs to provide assistance in the handling of rights infringement cases involving import and export goods, customs shall provide assistance.Article 22 Where customs conducts an investigation into the impounded goods suspected of infringing upon rights and the relevant details, the owner of Intellectual Property Rights and the consignee or consignor shall coordinate with the investigation.Article 23 An owner of Intellectual Property Rights may, after applying to customs for adoption of protective measures, apply to the people’s court for an order of cessation of the infringing act or preservation of property for the impounded goods suspected of infringing upon rights prior to the institution of action in accordance with the provisions of the PRC, Trademark Law, the PRC, Copyright Law or the PRC, Patent Law.Customs that receives the notice to assist in execution of an order of cessation of an infringing act or preservation of property from the p eople’s court shall provide assistance.Article 24 Customs shall release the impounded goods suspected of infringing upon rights in any of the following circumstances:1. customs impounds goods suspected of infringing upon rights according to Article 15 hereof, and has not received the notice to assist in execution from the people’s court within 20 working days from the date of impoundment;2. customs impounds goods suspected of infringing upon rights according to Article 16 hereof, and has not received the notice to assist in execution from the people’s court within 50working days from the date of impoundment, and cannot confirm that the impounded goods suspected of infringing upon rights has infringed upon Intellectual Property Rights after investigation;3. the consignee or consignor of the goods suspected of infringing upon patent rights requests customs to release his goods after providing a guarantee equal to the value of the goods; or4. customs considers that the consignee or consignor has sufficient evidence to prove that his goods have not infringed upon the Intellectual Property Rights of the owner of Intellectual Property rights.Article 25 Where customs impounds goods suspected of infringing upon rights according to the provisions hereof, the owner of the Intellectual Property Rights shall pay the relevant fees for storage, custody and disposal, etc. Where the owner of the Intellectual Property Rights has not paid the relevant fees, customs may deduct such fees from the guarantee he provides to customs, or request the guarantor to perform the relevant guarantee liability.Where goods suspected of infringing upon rights are confirmed as having infringed upon Intellectual Property Rights, the owner of the Intellectual Property Rights may include the relevant fees for storage, custody and disposal, etc. he has paid in the reasonable expenditure paid for cessation of the infringing acts.Article 26 Where customs discovers a case suspected of a criminal offence during implementation of protection of Intellectual Property Rights, it shall hand over the case to the public security authority according to law for handling.PART FOUR LEGAL LIABILITYArticle 27 Where impounded goods suspected of infringing upon rights are confirmed as having infringed upon Intellectual Property Rights after investigation by customs, customs shall confiscate the goods.After customs has confiscated the goods that have infringed upon Intellectual Property Rights, it shall notify the owner of the Intellectual Property Rights in writing of the relevant details of such goods.Where confiscated goods that have infringed upon Intellectual Property Rights can be used for public welfare, customs shall transfer the goods to the relevant public welfare organizations to be used for public welfare. Where the owner of the Intellectual Property Rights wishes to acquire the goods, customs may transfer the goods to the owner of the Intellectual Property Rights for compensation. Where confiscated goods that has infringed upon Intellectual Property Rights cannot be used for public welfare and the owner of the Intellectual Property Rights does not wish to acquire the goods, customs may auction off the goods according to law after removing the infringing characteristics. Where the infringing characteristics cannot be removed, customs shall destroy the goods.Article 28 Where articles carried or sent by mail by individuals into or out of China exceed the amount for personal use or the reasonable amount and infringeupon the Intellectual Property Rights stipulated in Article 2 hereof, customs shall confiscate such articles.Article 29 Where, after customs has accepted an application for record filing of protection of Intellectual Property Rights and for adoption of protective measures for Intellectual PropertyRights, an owner of Intellectual Property Rights cannot provide precise details and as a result, the goods infringing upon rights are not discovered, or the protective measures are not adopted in a timely manner or effectively, the owner of the Intellectual Property Rights shall bear the liability himself.Where, after an owner of Intellectual Property Rights has requested customs to impound goods suspected of infringing upon rights, customs cannot confirm whether the impounded goods suspected of infringing upon rights has infringed upon the Intellectual Property Rights of the owner of Intellectual Property Rights, or the people’s court rules that the goods have not infringed upon the Intellectual Property Rights of the owner of Intellectual Property Rights, the owner of Intellectual Property Rights shall be liable for compensation according to law.Article 30 Where the import or export of goods that infringe upon Intellectual Property Rights constitutes a criminal offence, criminal liability shall be pursued according to law.Article 31 Where the personnel of customs are derelict in their duties, abuse their authority or practice graft in their implementation of protection of Intellectual Property Rights, and a criminal offence is constituted, their criminal liability shall be pursued according to law. Where the same is insufficient to constitute a criminal offence, they shall be subjected to administrative penalty according to law.PART FIVE SUPPLEMENTARY PROVISIONSArticle 32 Where an owner of Intellectual Property Rights handles record filing of his Intellectual Property Rights with the General Administration of Customs, he shall pay the fee for record filing in accordance with the relevant State provisions.Article 33 These Regulations shall be implemented as of 1March 2004. The PRC, Customs Protection of Intellectual Property Rights Regulations promulgated by the State Council on 5 July 1995 shall be simultaneously repealed.。

法律英语学习-美国证据规则

法律英语学习| 美国证据规则美国的证据规则（或证据法）是关于证据的可采性(admissibility)、相关性(relevancy)、价值量(weight)和充分性(sufficiency)以及证明责任(Burden of Proof)等问题的法律原则和规则的总称。

证据的可采性处于核心的地位。

确定一个证据是否可以采用，主要应考察其实质性(materiality)、证明性(probativeness)和有效性(competency)。

而实质性和证明性合在一起即构成了相关性。

由于美国律师们在就对方证据提出反对时经常使用无相关性（irrelevant）、无实质性(immaterial)、无有效性（incompetent）这三个概念，所以证据的可采性规则也被概况为“三无”规则（”three I’s”）。

按照美国的传统法律，证据有两种基本类型(types of evidence)和三种基本形式(forms of evidence)。

两种基本类型包括直接证据(direct evidence)和间接证据(indirect evidence)或旁证(circumstantial evidence)。

三种基本形式包括言词证据(testimonial evidence)、实物证据(tangible evidence)和司法认知(judicial notice)。

其中，言词证据(testimonial evidence)是指为证人公开在法庭上所作的宣誓证词(sworn statements)。

广义而言，这类证据包括证人在宣誓后所作的口头和书面陈述，以及警察在审讯期间从证人、受害者或嫌疑犯取得的证词。

实物证据(tangible evidence)是指案件中的“展示物品”(physical exhibit)，它包括实在证据(real evidence)和示意证据(demonstrative evidence)。

前者指案件中“实实在在的东西”，如杀人用的枪、伪造的支票等；后者只能表明案件中某些情况的视听材料，如现场模型、图示等。

法律英语句子

1、The foreign investor has acquired more than 10 PRC domestic enterprises engaging in related industries within a year. 1、外国投资者一年内并购中国境内关联行业的企业超过10个。

2、The defendant challenged the admission of the evidence by the court on the ground that the evidence was irrelevant.2、被告以证据没有相关性为由反对法院对其予以采信。

3、The failure of either party at any time or times to require performance of any provision hereof shall in no manner affect its right at a later time to enforce the same．3、任何一方在任何时候未要求另一方履行本协议任一条款，并在不影响其以后强制执行该条款的权利。

4、“Affiliate”means any person or company that directly or indirectly controls a Party or is directly or indirectly controlled by a Party，including a Party's parent or subsidiary, or is under direct or indirect common control with such Party.4、“关联公司”指直接或间接控制一方(包括其母公司或子公司)或受一方直接或间接控制，或与该方共同受直接或间接控制的任何人或公司。