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  1. 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 2010.3Beijing

  2. Drug Administrative Law in China《药品管理法》的有关条款 • 《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

  3. 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本法制定的《药品生产质量管理规范》组织生产

  4. 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)

  5. 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)

  6. 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

  7. 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) • 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)

  8. Drug Administrative Law in China《药品管理法》的有关条款 • The main difference between dietary supplements and traditional Chinese medicine is as follows: • The labeling of dietary supplements or heath food shall not contain the 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). • 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)

  9. 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 Organization structure of the Chinese Pharmacopoeia Commission

  10. Chairman of ChP Commission Shao Mingli Director General of SFDA Vice Chairman Ma Xiaowei Vice Minister of Ministry of Health Wu Zhen Deputy Director General of SFDA Yu Wenming Deputy Director General of STCMA Chen Xinnian Vice Minister of Ministry of PLA Executive Committee 25 Subcommittee

  11. Executive Office: 70 member staves 9 divisions 常设机构 工作人员 70人 处室 9个 Standing Body of ChPC药典委员会常设机构

  12. Secretary General Prof. Wu Zhen Deputy Secretary General Zhou Fucheng Wang Ping Zhang Xianglin Director Zhang Huiyan P A Director Liu Xingchang D I Director Qian Zhongzhi T C M Director Guo zhongping B P Director Liu Wenhua M O Director Cai Keng P A D Director Lu Min E D Director Ren Zhongyuan D D Director Li Huiyi C P

  13. ChP Commission: Since 1950 ChP: 1953,1963,1977,1985,1990,1995,2000,2005 Besides ChP:1963~now (SFDA or MOH standards) Provincial Standards :1950s~2002 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) 1950~2002期间还曾存在省标 History of the Chinese Pharmacopoeia中国药典及国家标准历史概况

  14. 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 Technical Guidelines for Chinese Pharmacopoeia中国药典标准技术指南

  15. 《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》 《药材彩色图集》 《中药薄层色谱图集》 《药品标准工作手册》 《中国药品标准杂志》 《中国药典英文版》 Series work to Chinese Pharmacopoeia中国药典系列丛书

  16. Chinese Pharmacopoeia 2010 & National Standards《中国药典》2010及国家药品标准 • (一)2010版品种(monographs) • (二)2010版附录(general chapters, methods) • (三)2010版辅料(excipients) • (四)2010版凡例(general notice)

  17. Chinese Pharmacopoeia 2010(monographs)《中国药典》2010版品种 • Chinese Pharmacopoeia 2010 compile 4567 monographs, divided 3 volumes: • TCM: 2165 ( new 1019 ) • Chemicals: 2271 ( new 330 ) • Biologicals: 131 ( new 37 ) • 2010年版《中国药典》收载品种4567种,分为三部如下: • 中药:2165 (新增 1019 ) • 化学药:2271 (新增 330 ) • 生物制品:131 (新增 37 )

  18. Chinese Pharmacopoeia2010 (monographs)《中国药典》2010版品种 • Revision------- 2228 monographs, including • TCM: 634 • Chemicals: 1500 • Biologicals: 94 • 修订——2228种,其中 • 中药修订634种 • 化药修订1500种(重点为注射剂) • 生物制品修订94种 (修订比例约70%)

  19. Chinese Pharmacopoeia 2010(monographs)《中国药典》2010版品种 • Deletes------ 36 monographs ( to be reevaluated, ADR etc..) including 29 chemicals, 7 biologicals • 删除——对标准不完善、多年不生产、不良反应多的36种药品(化学药29种+生物制品7种)从药典撤下,纳入评价是否决定淘汰

  20. Chinese Pharmacopoeia 2010(Appendices)《中国药典》2010版附录 • TCM: 14 new admissions 47 revised • Chemicals: 15 new admissions 69 revised • Biologicals: 18 new admissions 39 revised • 中药 新增14个附录(如:黄曲霉素测定法、异常毒性、ICP-MS/微量多元素同时分析等),修订47个 • 化药 新增15个附录(如:溶血与凝聚、离子色谱、电导率、NMR、拉曼光谱等); 修订69个(如:渗透压;过敏反应) • 生物制品 新增18个附录(如:残留溶剂、牛血清白蛋白残留量测定),修订39个

  21. Chinese Pharmacopoeia 2010(Appendices)《中国药典》2010版附录 • Guideline for Impurities Analysis • Impurities in Standard be focused on (1)manufacturing process approved (2)raw materials confirmed • Violate GMP or changing process without approval or adultery can not predicted and covered by standard. No comply • Preparations focus on (1)degradated (2)toxic • Limitation see ICH • 杂质分析指导原则 • 标准中杂质主要针对(1)批准的工艺(2)确定的原辅料(3)贮存中产生 • (违反GMP,擅变工艺,搀伪造假-----不属正常标准关注项目而应作为违反有关规定认定不合格 • 制剂重点关注(1)降解产物(2)毒性杂质 • 杂质鉴定、检测以及定量限原则,同 ICH

  22. Chinese Pharmacopoeia2010 (Excipients)《中国药典》2010版辅料 • 1---New General Chapter on Excipients • 2---Enlarge excipients monographs • 3---Strengthen the requirements • 1—新增”药用辅料”通则: • 2--扩大辅料收载品种 • 3--严格辅料标准要求

  23. Chinese Pharmacopoeia 2010(General Notice)《中国药典》2010版凡例 • To define the Specification consist of 3 parts: general notice + monographs + appendices ( enforceable to ChP & national standards ) • To claim drug manufacturing shall be followed by GMP. It can not be regard as to meet the ChP requirements if violating GMP no matter if it comply with the standard • 明确国家药品标准由凡例与正文及其引用的附录共同构成。本部药典收载的凡例、附录对药典外其他药品国家标准具同等法定约束力 • 声明药品生产必须符合GMP,违反者即使按中国药典检验合格,亦不能认为符合药典规定

  24. Chinese Pharmacopoeia2010 (General Notice)《中国药典》2010版凡例 • Manufacturing process shall be validated & approved by SFDA • Drug derived from animal tissues must comply with the requirements for virus sterilization • Residue solvent shall be comply with the requirements in appendix ( equal to ICH ) • To reduce animal tests if it could be replaced by the precise method • 生产工艺应经验证,并经国务院药品监管部门批准,生产过程均应符合GMP • 动物组织来源的药品,应有明确的病毒灭活工艺 • 凡生产中引入有机溶剂,其残留量应符合附录规定 • 凡有准确的化学、物理的,应尽量采用,以减少动物试验

  25. 谢 谢 大 家