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The new trend of pharmacovigilance development, enterprises should change from passive response to active responsibility for drug safety

 Last Update: 2022-08-11
 Source: Internet
 Author: User

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Some time ago, the State Food and Drug Administration issued a notice on the "Guiding Principles of Pharmacovigilance Inspectio.

First, pharmacovigilance will accelerate to an important position;

The second is to pay more attention to the performance of the pharmacovigilance system, emphasizing the suitability, adequacy, and effectiveness of the system, rather than evaluating it solely on the basis of human, financial and material investment;

Third, the pharmacovigilance system will be continuously improv.

A good pharmacovigilance quality management system must be verified, improved and empowered through pharmacovigilance inspecti.

In the future, combined with the release of the "Guiding Principles for Pharmacovigilance Inspection", the first important part of strengthening pharmacovigilance is to prove safety, and further urge MAH to strengthen the establishment of a pharmacovigilance system, strengthen the corporate senior management's understanding of the significance of GVP, and promote the importance of " Safety signal” corporate culture construction; standardize entrusted pharmacovigilance work; urge enterprises to do a good job in risk identification, assessment and control to avoid major drug safety inciden.

It needs to be emphasized that inspection is not the purpo.

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