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Two regulations were deliberated and enacted

June 19th, 2020 | by

On March 30th, the State Administration for Market Regulation issued the “Measures for the Administration of Drug Registration” and  “Measures for the Supervision of Pharmaceutical Productions,” which will come into effect on July 1st. The two “Measures” stipulate that drug registration and manufacturing should be strictly supervised to make sure the safety of drugs. Besides, the system of Marketing Authorization Holder (MAH) should be implemented comprehensively. Moreover, a drug safety assurance system should be established to manage the life cycle of drugs.

《药品注册管理办法》等两规章审议通过   7月1日起执行

来源:医药网  2020.03.31

3月30日,市场监管总局发布《药品注册管理办法》,《药品生产监督管理办法》,两部规章将于2020年7月1日起正式施行。两项《办法》要求,应严格管理药品注册和药品生产,保障药品质量安全;全面落实上市许可持有人管理制度;建立药品质量保证体系,对药品的全生命周期进行管理。

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