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Improvement of the pharmacovigilance system

 Last Update: 2022-08-19
 Source: Internet
 Author: User

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The "Drug Administration Law" revised in 2019 clearly proposes that "the state establishes a pharmacovigilance system", and clarifies that the holder of the drug marketing authorization is the subject of pharmacovigilance responsibilit.

improving day by day

The first is to clarify the penalties for non-compliance with the pharmacovigilance quality management standar.

The second is to standardize the pharmacovigilance work of medical institution.

The third is to clarify the holder's pharmacovigilance obligation.

some thoughts

Based on the relevant content of the current pharmacovigilance legal system, the author puts forward some thoughts on the improvement and implementation of my country's pharmacovigilance system:

One is to further improve the supporting document.

The second is to strengthen the communication and cooperation of China's pharmacovigilance organization.

The third is to strengthen international cooperation and improve supervision efficienc.

(The author is a member of the Special Committee on Drug Governance System Research of China Drug Administration and Research Association)

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