文档介绍：药品生产监督管理方法(2020)
Measures for the Supervision and Administration of Drug Production (2020)【中英文对照版】
发布部门：国家市场监督管理总局发文字号
Where the alteration involves the contents specified in the drug production license and its annex, with approval of the medical products administrative department of the province, autonomous region, or municipality directly under the Central Government, it shall be reported to the Center for Drug Evaluation of NMPA for updating the relevant contents of the drug registration certificate and its annex.
Article 17 For change in a registration item of a drug production license, an application for alteration registration of the drug production license shall be filed with the original license issuer within 30 days after the market regulatory department verifies the alteration or the enterprise completes alteration. The original license issuer shall, within 10 days upon receipt of an application for alteration, handle the formalities of alteration.
Article 18 After a drug production license is changed, the original license issuer shall record the contents and time of alteration in the duplicate of the drug production license, reverify and re-issue an original drug production license according to the contents altered, and take back the former original drug production license. The period of validity of the drug production license shall remain unchanged.
Where drugs need to be produced continuously upon expiry of the validity period of a drug production license, an application for reissuance of a drug production license shall be filed with the original license issuer six months prior to the expiry of the validity period.
The original license issuer shall, in combination with an 原发证机关结合企业遵守药品管10
enterprise's compliance with the laws and regulations on drug administration and the management standards for drug production quality, and the operation of the quality system, conduct examination under the risk management principle, and make a decision of appr