PDF《中华人民共和国》

5 The drug regulatory department of the people'

s government at or above the provincial level shall organize inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing biological products specified by the drug regulatory department under the State Council, the inspection of which shall be conducted by the drug regulatory department under the State Council. The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council. 第六条 新开办药品生产企业、药品生产企 业新建药品生产车间或者新增生产剂型 的,应当自取得药品生产证明文件或者经 Article

6 Any newly-established drug manufacturer or manufacturer with newly Cbuilt drug manufacturing workshops or 第5页共40 页 中华人民共和国药品管理法实施条例 批准正式生产之日起30日内,按照规定向 药品监督管理部门申请《药品生产质量管 理规范》认证.受理申请的药品监督管理 部门应当自收到企业申请之日起6个月内, 组织对申请企业是否符合《药品生产质量 管理规范》进行认证;

认证合格的,发给 认证证书. newly-added dosage forms for production shall, within

30 days from the date it obtains the approval documents for manufacturing drug or from the date its formal production is approved, apply to the drug regulatory department for GMP certification as required. The drug regulatory department accepting the application shall, within six months from the date it receives the application, organize inspections as to the compliance with the GMP requirements by the applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed. 第七条 国务院药品监督管理部门应当设 立《药品生产质量管理规范》认证检查员 库.《药品生产质量管理规范》认证检查 员必须符合国务院药品监督管理部门规定 的条件.进行《药品生产质量管理规范》 认证,必须按照国务院药品监督管理部门 的规定,从《药品生产质量管理规范》认 证检查员库中随机抽取认证检查员组成认 证检查组进行认证检查. Article

7 The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the provisions of the drug regulatory department under the State Council. 第八条 《药品生产许可证》有效期为5年. 有效期届满,需要继续生产药品的,持证 企业应当在许可证有效期届满前6个月,按 照国务院药品监督管理部门的规定申请换 发《药品生产许可证》. 药品生产企业终止生产药品或者关闭的, 《药品生产许可证》由原发证部门缴销. Article

8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the provisions of the drug regulatory department under the State Council. Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority. 第九条 药品生产企业生产药品所使用的 原料药,必须具有国务院药品监督管理部 门核发的药品批准文号或者进口药品注册 Article