NMPA Guidance on Preparation of Pharmacovigilance

On 25 February 2022 the Center for Drug Reevaluation of Chinese NMPA published the notification on PSMF preparation guidance.

The Good Pharmacovigilance Practice (GVP) requires a drug marketing authorization holder (MAH) to create and maintain the pharmacovigilance system master file (PSMF). The PSMF is a description of the MAH's pharmacovigilance system and activities, which should be consistent with the current pharmacovigilance system and activities, and continue to meet relevant laws, regulations and practical work needs.

By creating and maintaining the PSMF, the MAH should ensure the compliance of the pharmacovigilance system, ensure that the pharmacovigilance system operates as required, be able to detect the defects and other risk information of the pharmacovigilance system in time, and ensure the integrity of the pharmacovigilance activities, orderly development and continuous improvement of the pharmacovigilance system.

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