Chinese Pharmacopoeia & National Standards中国药典中国药典及国家药品标准及国家药品标准Chinese Pharmacopeia Commission 中国国家药典委员会2010.3 BeijingDrug 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）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)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 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)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)Organization structure of the Chinese Pharmacopoeia Commission 9th ChP Commission:323 membersExecutives committee25 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Chairman of ChP CommissionShao Mingli Director General of SFDAVice ChairmanMa Xiaowei Vice Minister of Ministry of HealthWu Zhen Deputy Director General of SFDAYu Wenming Deputy Director General of STCMAChen Xinnian Vice Minister of Ministry of PLAExecutive Committee25 SubcommitteeStanding Body of ChPC 药典委员会常设机构Executive Office:70 member staves9 divisions 常设机构工作人员 70人处室 9个Secretary GeneralProf. Wu ZhenDeputy Secretary GeneralZhou FuchengWang PingZhang XianglinDirecto rQianZhongzhiTCMDirecto rLi HuiyiCPDirect orGuo zhongp ingBPDirect orZhang HuiyanPADirect orLiu Xingcha ngDIDirect orLiu WenhuaMODirecto rCai KengPADDirect orLu MinEDDirect orRen Zhongy uanDDHistory of the Chinese Pharmacopoeia 中国药典及国家标准历史概况 ChP Commission: Since 1950ChP: 1953,1963,1977,1985,1990,1995,2000,2005Besides ChP:1963now (SFDA or MOH standards)Provincial Standards :1950s2002 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）19502002期间还曾存在省标Technical Guidelines for Chinese Pharmacopoeia中国药典标准技术指南 Nomenclature PrincipleGuidelines for Analytical Method ApplicationDetailed 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Series work to Chinese Pharmacopoeia 中国药典系列丛书 Chinese Appro