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Pharmacovigilance Review

July 2009

European Biopharmaceutical Review

Elisabethann Wright discusses the need to revise the current EU pharmacovigilance provisions.

On December 10, 2008, the European Commission published its long-awaited proposal for a review of various aspects of the current EU legislation governing the authorisation of human medicinal products. The proposal includes propositions to revise the existing pharmacovigilance system. These elements of the proposal followed a detailed consultation procedure carried out by the European Commission. The replies to the consultation process demonstrated that a significant number of respondents felt that the current system was in great need of review. It was considered to be overly complex, with the available resources not always used to the best advantage. Such resources were often focused on meeting bureaucratic requirements, rather than proactively gathering data and information about the safety and risks of medicines. A need for rationalisation of the current system was also underlined.


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