16-FDA's Responsibilities and Activities
医疗器械监督管理条例英文版
医疗器械监督管理条例英文版Regulations on the Supervision and Administration of Medical Devices (English Version)Chapter 1: General ProvisionsArticle 1: These Regulations are formulated to strengthen the supervision and administration of medical devices, ensure their quality and safety, and protect the health and safety of patients and users.Article 2: These Regulations apply to the supervision and administration of medical devices within the territory of the People's Republic of China.Article 3: The State Drug Administration (SDA) is responsible for the supervision and administration of medical devices nationwide. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and administration of medical devices within their respective administrative regions.Chapter 2: Classification and Registration of Medical DevicesArticle 4: Medical devices are divided into three classes: Class I, Class II, and Class III, based on their potential risks to human health.Article 5: Class I medical devices are subject to registration with the SDA or its authorized departments. Class II and Class III medical devices shall obtain a registration certificate from the SDA or its authorized departments before they can be marketed or used.Article 6: The registration of medical devices shall adhere to the principles of scientific evaluation, risk classification, and lifecycle management. The registration procedures and requirements shall be determined by the SDA.Chapter 3: Production and Operation of Medical DevicesArticle 7: The production and operation of medical devices shall comply with relevant laws and regulations, as well as technical standards and requirements.Article 8: Medical device manufacturers shall establish a quality management system in accordance with the Good Manufacturing Practice (GMP) for medical devices. They shall also obtain a Medical Device Manufacturing License before engaging in production activities.Article 9: Medical devices shall be labelled with clear and accurate information, including the name, specifications, model, production date, expiration date, and manufacturer's information.Chapter 4: Clinical Trials and Adverse Event ReportingArticle 10: Clinical trials of medical devices shall be conducted in accordance with the provisions of the relevant regulations. The responsible party shall submit a clinical trial application to the SDA or its authorized departments for approval.Article 11: Any adverse event or abnormal reaction occurring during the use of medical devices shall be reported to the SDA or its authorized departments within the specified time limit.Article 12: Medical device manufacturers and users shall establish a system for monitoring and reporting adverse events. The SDA shall organize the collection, analysis, and evaluation of adverse event information to improve the safety of medical devices.Chapter 5: Supervision and InspectionArticle 13: The SDA and its authorized departments have the authority to conduct supervision and inspection of medical device production, operation, distribution, and use. Relevant units and individuals shall cooperate and provide necessary support during the inspection.Article 14: The SDA and its authorized departments have the power to order the suspension of production, operation, distribution, and use of medical devices that fail to meet the requirements, pose risks to human health, or are suspected of being counterfeit or substandard.Chapter 6: Legal LiabilityArticle 15: Any violation of these Regulations shall be dealt with in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations.Article 16: Violators who engage in the production and operation of medical devices without obtaining the necessary licenses or registrations shall be subject to administrative penalties, such as fines and confiscation of illegal income. In serious cases, criminal liability shall be pursued.Chapter 7: Supplementary ProvisionsArticle 17: These Regulations shall come into effect on the date of promulgation. The Regulations on the Supervision and Administration of Medical Devices issued by the State Council on January 1, 2002, shall be repealed simultaneously.Article 18: The SDA is responsible for the interpretation of these Regulations.Note: This English version is a translated version for reference purposes only. In case of any discrepancies between the Chinese version and this English version, the Chinese version shall prevail.。
FDAintroduction美国FDA简介.ppt
Prescription Drug Regulation
Good Old Days In the Early 1900s You Could Get Anything You Wanted No Concern for People Poisoning Themselves Few Effective Drugs Limited Rationale for Physician Supervision
Does Congress Defer to the FDA?
No, Congress Constantly Reviews the Agency in Committee Meetings
Why? Lots of Money Lots of Powerful Interests Drugs, Food Labeling Food and Drug Cranks
(A) Articles Recognized in the Official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or Official National Formulary, or Any Supplement to Any of Them Does the FDA Really Treat Every Thing in These As Drugs?
Harrison Narcotics Act Heroin Was the Hero Drug Because It Saved People From Morphine
FDA 行业指南 中英对照 待完成
Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS目录I.INTRODUCTION介绍II.BACKGROUND 背景A.Definitions 定义B.CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求C.Additional Considerations 其他需要考虑的事项III.QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS包装组件的合格要求以及质量控制A.Introduction 介绍B.General Considerations 通常要求rmation That Should Be Submitted in Support of an Original Application for Any DrugProduct 为支持任何药品的原始申请所必须提供的信息D.Inhalation Drug Products 吸入性药品E.Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药F.Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统G.Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末H.Other Dosage Forms 其他剂型IV.POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V.TYPE III DRUG MASTER FILES 药品主文件第III类A.General Comments 总体评述rmation in a Type III DMF 第III类DMF中包括的信息VI.BULK CONTAINERS 大包装容器A.Containers for Bulk Drug Substances 用于原料药的容器B.Containers for Bulk Drug Products 用于散装药品的容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls DocumentationI．INTRODUCTION介绍This document is intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics.3 This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics , issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs.4 This guidance is not intended to describe the information that should be providedabout packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。
FDA批准前现场检查的政策要求及实施概述(1)
摘要鉴于美国药品市场在全球市场中的特殊地位，和美国监管法规FDA的cGMP 在全球法规监管政策中的指导性作用，学习和掌握该法规的要求是中国制药企业在实施国际化战略的必由之路。
批准前现场检查是美国药品审批的重要步骤之一，其目的是检查企业的现场GMP状态和检查现场原始数据是否真实及和申报资料一致，现场检查的意见对药品申请是否获得批准至关重要。
本文通过对美国FDA的药品申请批准前检查的政策要求的阐述，并分析总结若干国内企业在接受批准前检查过程中的经验教训，并将中美两国药品批准前检查政策进行了对比分析，希望藉此帮助国内企业更好地理解美国批准前检查政策的要求，在贯彻实施的过程中注意一些关键因素的把握，从而为企业顺利通过美国药品审批提供一些借鉴。
论文简要介绍了美国FDA药品申请批准前检查的政策发展历史和法规依据，并阐述了药品申请批准前检查的目的、范围、方式、实际执行流程、检查政策的基于体系的检查方式的特点，以及六大体系在检查过程中的关注重点等。
并通过国内三个企业通过FDA的批准前检查的案例分析，总结批准前检查流程中的关键环节和如何进行检查后的整改措施及检查成果和教训，强调在完成批准前检查后的维持GMP状态的重要性。
通过分析国际药品市场、中国药品市场、中国制药企业的现状及自身优缺点，论证国际认证特别是美国FDA认证是中国企业发展壮大的必由之路，及获得国际认证后的重要意义，鼓励国内企业坚定国际化战略思维。
鉴于国际法规政策的多样性，论文专门将中美两国的批准前政策的异同点进行了对比分析，并讨论了不同规定的优缺点，方便国内企业更好地理解美国政策。
国家新版的GMP即将推行，其宗旨和美国的cGMP要求更加接近，此对比分析对于国内企业理解和遵循新的中国法规也有积极意义。
关键词：药品申请批准前检查现行药品生产质量管理规范批准前检查政策基于体系的检查The Requirement and E nforcement of FDA’s Pre-approval Inspection（PAI）PolicyAbstractGiven the special position of American drug market in the global market, and the guiding function of American supervise regulations（FDA ‘s cGMP）in global regular policy, it is inevitable for Chinese drug companies to learn and master the requirements of this regulations in order to execute their globalization strategies. Pre-approval inspection is an important step of American drug approval, whose purpose is to ensure that the on-spot GMP and on-spot statistics of companies are true and the same as written in the application material. Therefore, the opinion from the on-spot check is vital to the approval of the application. This thesis, with an illustration of the checking policy requirements prior to FDA drug application approval in U.S.A. , through an analysis of some lessons and experience of some domestic companies during the checking, and a comparison of the checking policies between the two countries, aims to help domestic companies gain a better understanding of the American pre-approval inspection policy, and pay attention to some crucial factors during the execution process, thus to provide some guidance for the companies to get a smooth approval from the American drug approval.The thesis gives a brief introduction of the policy history and the regulation resources of American FDA pre-approval inspection, and an illustration of the purpose, the range, the method, and the actual execution procedure of the check. It lays emphasis on the features of the checking method and the checking policy, and the different focuses of the six systems.By analyzing the current situation and their own advantages and disadvantages of the international drug market, Chinese drug market, and Chinese drug companies, the author draws a conclusion that the international qualification, especial American approval is an inevitable path for Chinese companies to take for their development. Thesignificance of obtaining international 认证encourages domestic companies to become international.With an brief introduction of some necessary steps before the application check, and the sample analysis of the actual check of three domestic companies, the thesis illustrates the critical steps during the process and how to improve after the check. It emphasizes the importance to sustain the GMP state after the check by focusing on the check result, the lesson, and the staff training.Given the variety of international regulations and policies, the author gives a special comparison and analysis of the similarities and differences of the approval polices between China and U.S.A.. and discusses their merits and demerits, therefore hopes to give the domestic companies a better understanding of American policies.The thesis does not give too much pages to the methods and skills about how to cope with the check, with the hope that the companies can regard the basic requirements of GMP as their real target, and perfect and maintain their GMP system through the check. We found that the new Chinese GMP which is to be practice recently is highly similar with American’s cGMP, therefore this analysis is also helpful for Chinese pharmaceutical companies to understand and follow Chinese policy.Key Words: drug, application Pre-approval inspection cGMPChinese PAI policy System-based inspection目录第1章前言 (1)第2章美国FDA药品申请批准前GMP检查（PAI）的要求 (2)2.1 FDA的cGMP检查的目的、分类，检查范围和方式 (4)2.2 美国FDA的药品申请批准前GMP检查的执行流程 (6)2.3 美国FDA的药品申请批准前GMP检查的 (9)第3章中国企业通过FDA的cGMP检查的意义 (15)3.1全球市场情况分析 (15)3.2中国市场分析 (18)cGMP认证的意义分析 (19)第4章制药企业如何准备FDA药品申请批准前检查以及实施检查后的整改22 4.1制药企业如何准备FDA的批准前检查 (22)4.2迎接和陪同FDA的批准前检查 (23)第5章中国企业在准备和应对cGMP批准前检查过程中案例分析 (24)第6章中国企业通过FDA的cGMP现场检查后维持cGMP状态及应对批准后检查（Post- AI）的必要措施 (34)6．1维持良好的GMP状态的常规性条件 (34)6．2在职员工的cGMP培训 (37)第7章中美两国GMP批准前检查政策的异同点对比和先进性分析 (38)7.1中国GMP批准前检查政策的简要介绍 (38)7.2中美两国批准前检查政策的异同点对比和先进性分析 (43)7.3针对中国SFDA的批准前检查政策的建议 (49)结束语 (50)参考文献 (51)致谢 (53)第一章前言制药行业是一个非常特殊的行业，其产业应用的科学基础涵盖物理、化学、生物学、微生物学、医学、材料学、矿物学、机械、电子、光学、流体力学、计算机等多种学科；由于其产品的使用和人类健康息息相关，所以这也是一个被高度关注，关乎国家政治稳定性的特殊行业。
FDA国外药厂检查指南
GUIDE(1) TO INSPECTIONSOF FOREIGN PHARMACEUTICAL MANUFACTURERS BACKGROUND背景There has been a significant increase in the number of foreign inspections of pharmaceutical manufacturing plants in the past few years. This trend is attributable mainly to the increase in the number of pre-approval inspections although the increase has been noted in other areas such as routine GMP inspections and compliance follow-up activities. Considering the resource-intensive nature of the foreign inspection program, it has become clear that effective and efficient inspectional coverage is crucial to the successful management of the program and that can be achieved only through maintenance of consistency and uniformity of inspection and enforcement activities.在最近几年医药制造厂外检查数量显著增加。
这一趋势主要是由增加的前置审批检查的次数虽然增加了在其他领域如日常GMP检查和合规性的后续活动记录。
FDA英语术语大全
FDA英语术语大全FDA是什么意思，FDA得英文全称是什么？FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究完毕） NDA（NEW DRUG APPLICATION）：新药申请 ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品） TREATMENT IND：研究中的新药用于治疗ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为慎重起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、 NDA、ANDA时才能参考其内容） HOLDER：DMF持有者 CFR（CODE OF FEDERAL REGULATION）：（美国）联邦法规 PANEL：专家小组 BATCH PRODUCTION：批量生产；分批生产 BATCH PRODUCTION RECORDS：生产批号记录 POST-OR PRE- MARKET SURVEILLANCE：销售前或销售后监视 INFORMED CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意承受治疗或试验） PRESCRIPTION DRUG：处方药 OTC DRUG （OVER—THE—COUNTER DRUG）：非处方药以上信息中国医药资讯网 FDA（FOOD AND DRUG ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL NEW DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究完毕） NDA（NEW DRUGAPPLICATION）：新药申请 ANDA（ABBREVIATED NEW DRUG APPLICATION）：简化新药申请 EP诉（EXPORT APPLICATION）：出口药申请（申请出口不被批准在美国销售的药品） TREATMENT IND：研究中的新药用于治疗 ABBREVIATED（NEW）DRUG：简化申请的新药 DMF（DRUG MASTER FILE）：药物主文件（持有者为慎重起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
FDA introduction 美国FDA简介
Does Congress Defer to the FDA?
No, Congress Constantly Reviews the Agency in Committee Meetings Why? Lots of Money Lots of Powerful Interests Drugs, Food Labeling Food and Drug Cranks
Conflicts in Clinical Trials
Life Saving Drugs Patients want a cure Drugs probably do not work What if the drug is available outside the trial? Do you quit a drug that works to get on the trial? What if the patient Lies? Non-Life Saving Drugs Pay the subjects? Docs get paid by the patient Companies want positive results
Prescription Drug Regulation
Good Old Days In the Early 1900s You Could Get Anything You Wanted No Concern for People Poisoning Themselves Few Effective Drugs Limited Rationale for Physician Supervision Harrison Narcotics Act Heroin Was the Hero Drug Because It Saved People From Morphine
美国FDA原料药生产质量管理规范( 中英文)
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OFRAW MATERIALS BY FDA美国FDA原料药生产质量管理规范（中英文）Table of Contents 目录1. INTRODUCTION 简介1.1 Objective 目的1.2 Regulatory Applicability法规的适用性1.3 Scope 范围2. QUALITY MANAGEMENT .质量管理2.1 Principles 总则2.2 Responsibilities of the Quality Unit(s) 质量部门的责任2.3 Responsibility for Production Activities 生产作业的职责2.4 Internal Audits (Self Inspection) 内部审计（自检）2.5 Product Quality Review 产品质量审核3. PERSONNEL 人员3.1 Personnel Qualifications 人员的资质3.2 Personnel Hygiene 人员卫生3.3 Consultants 顾问4. BUILDINGS AND FACILITIES 建筑和设施4.1 Design and Construction 设计和结构4.2 Utilities 公用设施4.3 Water 水4.4 Containment 限制4.5 Lighting 照明4.6 Sewage and Refuse 排污和垃圾4.7 Sanitation and Maintenance 卫生和保养5. PROCESS EQUIPMENT 工艺设备5.1 Design and Construction 设计和结构5.2 Equipment Maintenance and Cleaning 设备保养和清洁5.3 Calibration. 校验5.4 Computerized Systems 计算机控制系统6. DOCUMENTATION AND RECORDS 文件和记录6.1 Documentation System and Specifications 文件系统和质量标准6.2 Equipment cleaning and Use Record 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产记录（批生产和控制记录）6.6 Laboratory Control Records 实验室控制记录6.7 Batch Production Record Review 批生产记录审核7. MATERIALS MANAGEMENT 物料管理7.1 General Controls 控制通则7.2 Receipt and Quarantine 接收和待验7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试7.4 Storage 储存7.5 Re-evaluation 复验8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制8.1 Production Operations 生产操作8.2 Time Limits 时限8.3 In-process Sampling and Controls 工序取样和控制8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批8.5 Contamination Control 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General 总则9.2 Packaging Materials 包装材料9.3 Label Issuance and Control 标签发放与控制9.4 Packaging and Labeling Operations 包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures 入库程序10.2 Distribution Procedures 分发程序11. LABORATORY CONTROLS 实验室控制11.1 General Controls 控制通则11.2 Testing of Intermediates and APIs 中间体和原料药的测试11.3 Validation of Analytical Procedures 分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs 原料药的稳定性监测11.6 Expiry and Retest Dating 有效期和复验期11.7 Reserve/Retention Samples 留样12. VALIDATION .验证12.1 Validation Policy 验证方针12.2 Validation Documentation 验证文件12.3 Qualification 确认12.4 Approaches to Process Validation 工艺验证的方法12.5 Process Validation Program 工艺验证的程序12.6 Periodic Review of Validated Systems 验证系统的定期审核12.7 Cleaning Validation 清洗验证12.8 Validation of Analytical Methods 分析方法的验证13. CHANGE CONTROL 变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection 拒收14.2 Reprocessing 返工14.3 Reworking 重新加工14.4 Recovery of Materials and Solvents 物料与溶剂的回收14.5 Returns 退货15. COMPLAINTS AND RECALLS 投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者17.1 Applicability 适用性17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management 质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability 稳定性17.6 Transfer of Information 信息的传达17.7 Handling of Complaints and Recalls 投诉和召回的处理17.8 Handling of Returns 退货的处理18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General 总则18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存18.3 Cell Culture/Fermentation 细胞繁殖/发酵18.4 Harvesting, Isolation and Purification 收取、分离和精制18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤19. APIs for Use in Clinical Trials 用于临床研究的原料药19.1 General 总则19.2 Quality 质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials 原料的控制19.5 Production 生产19.6 Validation 验证19.7 Changes 变更19.8 Laboratory Controls 实验室控制19.9 Documentation 文件20. Glossary 术语1. INTRODUCTION 1. 简介1.1 Objective 1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。
WHO验证指南（2016版）解读
WHO验证指南（2016版）解读ECA官网最近昨日挂出关于WHO公布验证指南（草案）的新闻，并对这份指南（草案）进行了解读，评价其为工艺验证总指南。
关于这份草案的本公众号已于6月26日对其中英文对照版进行公示，有兴趣的可以查看6月26日推送的文章——《WHO验证指南2016（草案）》，下面是这份指南的解读：At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.2015年底，WHO采纳了其最近技术标准附录7。
附录7为非无菌工艺验证提供了支持。
现在，WHO指南有了进一步变化。
变化之一是关于工艺验证的指南，现在草案已发布，征求意见截止日期为2016年7月12日。
这里是对此草案的一些分析。
The draft contains 21 pages divided into 13 chapters and one part with references.草案包括21页，分为13章和参考文献。
The guideline serves as a sort of umbrella guideline and should replace in the future Annex 4 of the WHO Technical Report Series No. 937 from 2006. In so far, the draft refers to other guidelines about the topic validation which will thus have to be updated too as subordinated guidelines (Appendices). The following appendices are named:该指南是类似伞样的指南，将来会替代2006年WHO技术报告第937号中的附录4。
EU GMP 附录16：药品质量受权人签发证书和放行批产品-英文
1.4. For manufacturing steps performed at sites in the EU each manufacturing site must have at least one QP.
1.4.1 Where the site only undertakes partial manufacturing operations in relation to a batch, then a QP at that site must at least confirm that the operations undertaken by the site have been performed in accordance with GMP and the terms of the written agreement detailing the operations for which the site is responsible. If the QP is responsible for providing confirmation of compliance for those operations with the relevant MA, then the QP should have access to the necessary details of the MA.
FDA行业指南中英对照待完成
FDA行业指南中英对照待完成FDA Industry Guidance - FDA行业指南Introduction - 引言Scope - 范围This guidance applies to manufacturers, distributors, importers, and other participants in the food, drug, and medical device industries. - 本指南适用于食品、药品和医疗器械行业的制造商、分销商、进口商及其他参与者。
Definitions - 定义For the purposes of this guidance, the following definitions apply: - 为了本指南的目的，将适用以下定义：1. Food - 食品Any article used for food or drink for man or animals. - 任何用于人类或动物的食品或饮料。
2. Drug - 药品Any substance intended for use in the diagnosis, cure, treatment, or prevention of disease. - 任何用于诊断、治愈、治疗或预防疾病的物质。
3. Medical Device - 医疗器械Any instrument, apparatus, or device intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. - 任何用于诊断、治愈、缓解、治疗或预防疾病的仪器、装置或设备。
4. Manufacturer - 制造商Product Quality Requirements - 产品质量要求Manufacturers should ensure that products meet the appropriate quality standards established by the FDA. - 制造商应确保产品符合FDA制定的适当质量标准。
FDA对产品开发报告的要求（英文）
FDA对产品开发报告的要求（英文）FDA对产品开发报告的要求（英文）Product development reports have always existed in one form or another in large research and development sections of research based pharmaceutical firms. They represent the culmination of the R&D effort to develop a medicinal product that presents in one document all the basic information necessary to obtain a meaningful understanding of the drug product's active moiety, how the finished product was developed, what its characteristics and attributes are and what data and reports are available to support its safety and efficacy. The Product Development Report, if properly prepared, serves as a basis for the preparation of a Technology Transfer Document, assists in the transition from R&D to Production of the finished approved pharmaceutical product, and identifies critical control points and parameters for process validation.There are no legal or regulatory requirements for a firm to produce a "Product DevelopmentReport." FDA, in public presentations discussing the pre-approval program and the drug approval process, has encouraged firms to prepare product development reports. They have, however, taken no official stand on their preparation. The preparation of such a report is encouraged because it provides the agency with a detailed summary of the drug product and a list of referenced documents that will enhance and expedite the pre-approval inspection. A well-done report provides the FDA investigator with an impression that the firm truly has its act together, understands the drug development process and it's requirements, and has dotted all the i's and crossed all the t's. Aconcise report that references supporting data and files will start the pre-approval inspection off on the right foot. It will assure FDA that the products commercial application (NDA/ANDA) is supported by sound scientific data, process and methods are validated, procedures are in place, etc.The report is a summary and should seldom exceed 100 pages in length. A table of contentsor index should be included.-Content of Product Development Report-Purpose Section This part of the report will describe why the report is written and what areas are covered.Introduction Describe, in summary form, drug development from the IND submission to commercial production. Gantt charts may be included or attached to display the initiation, key intermediate steps and completion of work in critical areas such as characterization of the chemical, validation of methods, toxicity studies, clinical studies, production changes and scale-up and process validation. Sucha chart may also be used to show times of NDA submissions and amendments.Product Description SectionThis section is designed to describe and summarize the drug products indications, efficacy, and safety in lay language.Physical Characteristics of the New DrugSubstance In this section, provide the structural and molecular formula, list all the drug substances' qualities and specifications, and provide some basic information on its synthesis or derivation.Biological Characteristics of the Drug ProductThis section should summarize the studies conducted andthe results obtained for the following attributes; dose proportionality, bioavailability and bioequivalence.Process Definition SectionThis section should provide information on the theoretical unit formula per dose including inactive ingredients excipients, etc. A discussion of why certain excipients were selected and information on how the final formula was developed should be provided.This section should also include a description of the manufacturing process and conditions, any information on sterility and processing parameters, ideal batch sizes, and processing conditions vs. actual experience. A description of the manufacturing equipment, in process test results, and final dosage form test results should be included.Stability SectionIn this section, describe stability of active drug substances and finished dosage form product.Include batch sizes, storage conditions, analytical methodology, specifications analyzed for, etc. Include the number of batches for which stability data has been obtained.Process Validation SectionThis section should be a summary of the process and cleaning validation studies performed. Include information on mixing, filling, sterilization, etc.SummaryThe results of all the previously submitted studies enables us, at this point, to decide on the final product formula, process, indications, warning, etc. Include in this section a description of the final drug product(s) and delivery systems, if applicable. Include a discussion of the consistency of the process, failures (ifany), scale-up problems (if any), bioequivalency and rationale for final decisions.Appendices (either included or referenced)Product Manufacturing Batch RecordValidation Protocol and Report (if available)Stability DataAppropriate references (clinical, toxicological,pharmacology data, etc.)As mentioned above, the “Product Development Report” can be an instrumental tool to the proper preparation and implementation of the technology transfer taking the product from Research and Development to commercial production. Such a transfer must take place using detailed procedures describing the items to be checked during manufacture (validation), assuring analytical (in-process, finished product and stability) methods are validated in the Q.C. laboratory and assist in the development and implementation of appropriate cleaning validation. A suggested Technology Transfer document will be the subject of a future Advisory and Analysis.。
FDA公布已批准变更的可比性方案应用指南草案
FDA公布已批准变更的可比性方案应用指南草案翻译：julia 来自：蒲公英GMP News27/04/2016FDA releases draft guidance on the use of comparability protocols for post approval changesFDA公布已批准变更的可比性方案应用指南草案On April 19, 2016, the US Food & Drug Administration (FDA) released a draft guidance for industry 'Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information'. Comments and suggestions regarding the draft guideline should be submitted within 60 days of publication.2016年4月19日，美国FDA公布了行业指南”人用药品和生物制品可比性方案：CMC信息“草案。
对于指南草案的意见和建议应在公布之后 60天内提交。
The guidance replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). A CP is a comprehensive, prospectively written plan for assessing the effect of proposed CMC postapproval changes on the identity, strength, quality, purity, and potency of a drug product or a biological product. Using a CP in an original application or prior approval supplement (PAS) will, in manycases, facilitate the subsequent implementation and reporting of CMC changes. This could result in moving a product into distribution or facilitating a proactive approach to reinforcing the drug supply chain sooner than without a submitted protocol.该指南取代了2003年公布的指南草案。
美国FDA指导原则药品不良反应上市后报告指南英文原版
美国FDA指导原则药品不良反应上市后报告指南英文原版Title: FDA Guidelines for Reporting Post-Market Drug Adverse ReactionsIntroductionThe U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of drugs available in the market. One aspect of this responsibility is the monitoring and reporting of adverse reactions associated with the use of drugs post-marketing. This guideline aims to provide detailed instructions on how to report drug adverse reactions to the FDA.PurposeThe purpose of this guideline is to facilitate the reporting of adverse reactions associated with drugs that have been approved and are being used in the market. It enables healthcare professionals, consumers, and manufacturers to report adverse reactions promptly, thereby helping the FDA identify potential safety issues and take appropriate regulatory actions to protect public health.ScopeThe reporting of adverse reactions under this guideline applies to all prescription and non-prescription drugs,including biologics, vaccines, and generic drugs, indicated foruse in the United States. The guideline covers adverse reactions occurring both within and outside the United States.Reporting Requirements1. Mandatory Reporting: Manufacturers, packers, and distributors of drugs approved by the FDA must submit periodic safety reports containing information on any adverse drug reactions they receive.2. Voluntary Reporting:b. Consumers: Patients, caregivers, and other consumers can also report adverse reactions directly to the FDA using the MedWatch Reporting System.c. Foreign Regulatory Authorities: If an adverse reaction occurs outside the United States, foreign regulatory authorities are encouraged to report such events to the FDA.Reportable Events1. Serious Adverse Reactions: Any adverse reaction to a drug that results in death, a life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability, congenital anomaly, or requires intervention to prevent permanent impairment or damage.3. Adverse Reactions in Special Populations: Adverse reactions specific to particular populations, such as pregnantwomen, infants, elderly individuals, or individuals with certain medical conditions.4. Known Adverse Reactions: Adverse reactions that are already listed in the drug's labeling, but occur at a higher frequency or severity than expected.Reporting ProcessReporting adverse reactions involves the following steps:2. Submit the report electronically to the FDA through the MedWatch Reporting System.3. Include all available supporting documentation, such as laboratory test results, medical records, and any additional relevant information.Confidentiality and ProtectionConclusion。
FDA行业指南 委托生产质量协议 中英文
Contract Manufacturing Arrangements for Drugs: Quality AgreementsGuidance for Industry行业指南：药品委托生产安排：质量协议U.S. Department of Health and Human Services Food and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)Guidance for IndustryAdditional copies are available from:Office of Communications, Division of Drug Information Center for Drug Evaluation and ResearchFood and Drug Administration10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353Email: druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOffice of Communication, Outreach and Development Center for Biologics Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 71, Room 3128Silver Spring, MD 20993-0002Phone: 800-835-4709 or 240-402-8010Email: ocod@/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orPolicy and Regulations Staff, HFV-6Center for Veterinary Medicine Food and Drug Administration7519 Standish Place, Rockville, MD 20855/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)TABLE OF CONTENTS 目录TABLE OF CONTENTS 目录 (3)I. INTRODUCTION前言 (4)II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING指定委托生产的人和事 (6)III. RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT MANUFACTURING委托生产所涉及各方的职责7 IV. DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS在质量协议中记录CGMP活动 (10)A.What Is a Quality Agreement? 什么是质量协议？ (10)B.Elements of a Quality Agreement 质量协议的要素 (11)V. ILLUSTRATIVE SCENARIOS案例 (17)A.Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受托场所是否都对CGMP负责？18B.CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 适用于所有合同场所，包括分析化验室的CGMP (19)C.Owners and Contract Facilities Perform Change Control Activities 所有者和受托方实施变更控制活动20VI. RECOMMENDATIONS建议 (21)Contract Manufacturing Arrangements for Drugs:QualityAgreementsGuidance for Industry1行业指南：药品委托生产安排：质量协议I.INTRODUCTION 前言This guidance describes FDA’s current thinking on defining, establishing, and documentingmanufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how partiesinvolved in contract drug manufacturing can use quality agreements to delineate theirmanufacturing activities to ensure compliance with CGMP.本指南讲述了FDA当前对于受到CGMP约束的药品委托生产所涉及各方如何定义、设立和记录生产活动的看法，尤其是药品委托各方如何使用质量协议来描绘其生产活动，以确保符合CGMP。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
2. FDA: Policeman or Teacher?
A few years ago, the big thing for the college age crowd was to dwell on the question, “who am I?”
safe and effective; (3) cosmetics are safe; (4) the use of radiological products does not result in unnecessary exposure to
radiation; and (5) all of these products are honestly and informatively labeled.
A medical device may be as basic as sterile gauze or as sophisticated as a heart pacemaker. Electronic-radiological
products are equally varied, including, for instance, TV sets, microwave ovens, and mercury-vapor lamps; machines used in
further data as well as approvals and disapprovals).
FDA regulates only those products over which it has jurisdiction. For example, the Agency does not regulate meat and
by FDA at one time or another, some of them with considerable frequency. In fiscal year 1999, over 70,000 samples of domestic
and imported products were analyzed in FDA labs. Also FDA processed over 50,000 public inquiries, and responded to more than
with spot checks of driving speed and sampling of tax returns for auditing. Similarly, the FDA must primarily rely on the
voluntary compliance of those who operate within the professions and industries that are responsible for the products over
which the FDA has jurisdiction. This voluntary compliance is encouraged by a parallel program of regulatory enforcement via
industrial processes largely unknown to the public; and the X-ray machine common to every dentist’s office and hospital.
The food and drug industry is as vast as it is complex. At least 125,000 establishments in the United States are inspected
it is similarly uncertain as to its proper role or function. In particular, the Agency has often acted ambivalent and
wavering as it has moved back and forth between at least two distinctly different roles: namely, that of a police officer
30,000 requests for information under the authority of the Freedom of Information Act. In 1999, FDA took action on almost
18,000 petitions and applications for approval of drugs, medicated feeds, and food additives. (Actions include requests for
sterility of an adhesive bandage, and the safety of their medical and dental x-rays. FDA’s goal is to see that this
confidence is warranted by ensuring industry’s compliance with federal laws regulating products in commerce.
Even the general terms employed here suggest the broad range of product categories under FDA’s regulatory jurisdiction.
However, they may not readily suggest the myriad of products within each category. Take drugs for example, besides the
The Goal
In the simplest terms, the provisions of these laws are intended to ensure that: (1) food is safe and wholesome; (2)
drugs (both human and veterinary), biological products (e.g., vaccines and blood for transfusion), and medical devices are
animals, often mixed with feeds, are closely monitored because remaining drug residues in the animal tissue are ultimately
consumed at dinner tables.
regulatory body and must operate in a manner to assure compliance.
But compliance itself can be achieved by at least two different routes. There is, of course, that of close supervision
prescription filled by your pharmacist and the aspirin you buy over the counter, both fluoride toothpaste and dandruff
shampoo are legally defined as drugs. Veterinary drugs must also beons for food producing
and that of a teacher.
By law, the FDA has responsibility to oversee the purity, quality, identity, safety, usefulness, and related
characteristics of the nation’s food, drug, and cosmetic supply. With this legal mandate, the Agency is clearly a
1. What is FDA?
The Food and Drug Administration has been described as the principal consumer protection agency of the Federal Government,
and with good reason. A good number of the products found in a grocery or drug store are regulated by the FDA. Among the many
Federal regulatory agencies, no other agency touches the day-to-day life of citizens so directly. Most people take for
granted the wholesomeness of the food they buy, the truth of the label on a can of beans or a bottle of medicine, the
Not only do persons undergo such identity crises but at times organizations and agencies also experience this type of