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The European Implementing Regulation on Pharmacovigilance Activities

The proposed revision is a step towards greater independence from drug companies and better control of the quality and disclosure of data, but additional improvements are needed.

In its response to the public consultation by the European Commission on a revision of the 2012 Implementing Regulation relating to pharmacovigilance activities, Prescrire observes that the proposed amendments are a step towards greater independence from drug companies and better quality control and disclosure of pharmacovigilance data.

However, additional improvements are needed.

A summary appears in the September 2022 issue of Prescrire International.

©Prescrire 1 September 2022

Source: "The European Implementing Regulation on Pharmacovigilance Activities" Prescrire International 2022; 31 (240): 223. Subscribers only.

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For more information:

"Prescrire's response to
the public consultation on
the revision of European
pharmaceuticals legislation"
Advancing healthcare policy
(December 2021)
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