中国药典及国家药品标准.ppt

Chinese Pharmacopoeia & National Standards
《中国药典》及国家药品标准
Chinese mission
中国国家药典委员会
Beijing
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
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