Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (11): 666-669.
DOI: 10.19803/j.1672-8629.2019.11.05

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MAHs’ Principal Responsibilities for Safety Risk during the Whole-life Cycle of Drugs

ZHONG Lumiao   

  1. Hunan Center for Drug Evaluation and Authentication and ADR Monitoring, Changsha Hunan 410013, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

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Abstract: Objective To enhance MAHs’awareness of principal responsibilities for drug safety risks.Methods The causes of pre-marketing and post-marketing risks were analyzed. The strengths of regulatory models overseas were summarized.Results & Conclusion In the whole-life cycle of drugs, MAHs, as the main body of research and development, production and economic benefit, should bear the principal responsibilities for drug safety risks.

Key words: MAHs, whole-life cycle, drug safety risk, principal responsibility

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