中国药典及国家药品标准

症
• 中药具有治疗作用，其药材或
成药均应标有功能主治、用法
用量(以防误用)
Organization structure of the Chinese Pharmacopoeia Commission
9th ChP Commission: 323 members Executives committee 25 subcommittees • 第九届药典委员会 • 323位委员 • 执行委员会 • 专业委员会 25个
• 食品补充剂与中药的主要不同： • 食品补充剂或保健食品的标签 不应标明用于某种疾病的适应
indication for specific diseases..
• The traditional Chinese medicines have therapeutic actions, the labeling of the crude drugs and their preparations shall include the Action and Indication, Usage & Dosage (in case of misused).
中国药典标准技术指南
• Nomenclature Principle • Guidelines for Analytical Method Application • Detailed Rules for Drafting Drug Standards • 药品命名原则 • 药品分析方法应用原则 • 药品标准编写细则
95,2000,2005
• Besides ChP:1963～now (SFDA or MOH standards)
• Provincial Standards :1950s～
2002
• 1950~2002期间还曾存在省标
Technical Guidelines for Chinese Pharmacopoeia
Series work to Chinese Pharmacopoeia 中国药典系列丛书
• 《Chinese Approved Drug Names》 • 《The Atlas of IR Spectra》 • 《Clinical Guide to the ChP》 • 《The Color Atlas of Traditional Chinese Crude Drug》 • 《The Atlas of TLC Identification for TCM》 • 《Manual of Drug Standardization》 • 《Drug Standards of China》 journal • 《ChP 2010 English Edition》 • 《中国药品通用名称》 • 《药品红外光谱集》 • 《临床用药须知》
统药，充分发挥其在预防、医
疗和保健中的作用。国家保护 野生药材资源，鼓励培育中药
材
Drug Administrative Law in China 《药品管理法》的有关条款
• Article 9 Drug manufacturers shall conduct production according to the Good Manufacturing Practice for Pharmaceutical Products (GMP) formulated by the drug regulatory department under the State Council on the basis of this law. • 第九条 药品生产企业必须按照 国务院药品监督管理部门依据
Chairman of ChP Commission
Shao Mingli Director General of SFDA
Vice Chairman Ma Xiaowei Wu Zhen Yu Wenming Chen Xinnian Vice Minister of Ministry of Health Deputy Director General of SFDA Deputy Director General of STCMA Vice Minister of Ministry of PLA
Direct or
Liu Xingcha ng
Direct or
Liu Wenhua
Directo r
Cai Keng
Direct or
Lu Min
Direct or
Ren Zhongy uan
T C M
C
P
B P
P
P D I M O A D
E D D D
A
History of the Chinese Pharmacopoeia 中国药典及国家标准历史概况
本法制定的《药品生产质量管
理规范》组织生产
Drug Administrative Law in China 《药品管理法》的有关条款
• Article 10 A drug shall be produced in conformity with the National Drug Standard & with the production processes approved (by SFDA) • Article 11 The raw materials and excipients for manufacture of pharmaceutical products shall meet the requirements for medicinal use ( difference between raw materials and drug substances ) • 第十条 药品必须按照国家药品 标准和国务院药品监督管理部 门批准的生产工艺进行生产
• 第一百零二条 药品（定义） • 是指用于预防、治疗、诊断人 的疾病，有目的地调节人的生 理机能并规定有适应症或者功 能主治、用法用量的物质 • 包括中药材、中药饮片、中成 药、化学原料药及其制剂等
•
•
• (说明:在中国“中药”是按药品
严格管理而非食品或营养补充 剂)
Drug Administrative Law in China 《药品管理法》的有关条款
• The main difference between dietary
supplements and traditional来自百度文库Chinese
medicine is as follows: • The labeling of dietary supplements or heath food shall not contain the
Prof. Wu Zhen
Deputy Secretary General Zhou Fucheng Wang Ping Zhang Xianglin
Directo r
Qian
Zhongzhi
Directo r
Li Huiyi
Direct or
Guo zhongp ing
Direct or
Zhang Huiyan
Chinese Pharmacopoeia & National Standards
《中国药典》及国家药品标准
Chinese Pharmacopeia Commission 中国国家药典委员会
2010.3
Beijing
Drug Administrative Law in China 《药品管理法》的有关条款
• 第十一条 生产药品所需的原料、
辅料，必须符合药用要求（注 意原料与原料药的区别；药用 要求的重要指标之一即国家药 品标准）
Drug Administrative Law in China 《药品管理法》的有关条款
• Article 31 Production of a new drug or generics shall be subject to approval (by SFDA), and a drug approval number shall be issued for it (SFDA issue a approval number to drug substances). • Article 32 Drugs shall meet the National Drug Standards(ChP,MOH&SFDA Sta) • 第三十一条 生产新药或者已有 国家标准的药品的，须经国务 院药品监督管理部门批准并发 给药品批准文号（我国对原料 药实行批准文号管理） • 第三十二条 药品必须符合国家 药品标准(药典,部/局颁)
Executive Committee 25 Subcommittee
Standing Body of ChPC 药典委员会常设机构
Executive Office: 70 member staves 9 divisions
• 常设机构 工作人员 70人 处室 9个
Secretary General
Drug Administrative Law in China 《药品管理法》的有关条款
• Article 102 Drugs refer to articles which are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, for which indications, usage and dosage are established Including Chinese crude drugs, prepared slices of crude drugs, traditional Chinese medicine preparations, chemical drug substances & their preparations (Note: TCM administered strictly as drug, not as dietary supplements or health food ,in China)
• ChP Commission: Since 1950 • ChP: 1953,1963,1977,1985,1990,19 • 中国药典委员会成立于1950年 • 先后出版1953，1963，1977， 1985，1990，1995，2000， 2005，2010 • 《中国药典》以外尚有国家标 准约7000个品种（部、局颁标 准）
Drug Administrative Law in China 《药品管理法》的有关条款
• Article 32 Drugs shall meet the national drug standards. The Chinese Pharmacopoeia and the drug standards issued by the drug regulatory department under the State Council shall sever as the national standards. the drug regulatory department under the State Council shall organize a pharmacopoeia commission ,which shall be responsible for formulating and revising the national drug standards • 第三十二条 药品必须符合国家 药品标准。国务院药品监督管 理部门颁布的《中国药典》和 药品标准为国家药品标准。国 务院药品监督管理部门组织药 典委员会，负责国家药品标准 的制定和修订
• 《Drug Administration Law 》 effective as of Dec. 1, 2001 • Article 3 The State develops both modern and traditional medicines to give full play to their role in prevention and treatment of diseases and in maintenance of health • The State protects the resources of natural crude drugs and encourages the cultivation of Chinese crude drugs • 《药品管理法》 2001年12月1 日实施 • 第三条 国家发展现代药和传