Analysis on the Drugs Administration Law (Draft for Consultation)

作者/编者:Huang Jianwen
作者单位:金杜律师事务所
创作年代:2017
出处/来源:金杜律师事务所
学科分类:经济法学
所属机构:金杜律师事务所
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摘要

In order to deepen the reform in the field of drugs, the China Food and Drug Administration issued the Drugs Administration Law (Draft for Consultation) (“Draft”) on 23 October 2017. The Draft incorporates and reflects material contents in the reform of drugs field in recent years, including fully implementing the Marketing Authorization Holder system, cancelling certificates of Good Manufacturing Practice and Good Supply Practice, carrying out records management for clinical trial institution and emphasizing legal liabilities on relevant entities in drug research and trial.

关键词: Drugs Administration; MAH system; Clinical Trial

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Analysis on the Drugs Administration Law (Draft for Consultation)

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