Tuesday 04 February 2014 EU Sets The Stage For Increased Pharmacovigilance Oversight And Harmonization

By Amanda Sibley, Head of Safety Services, ProductLife Group

With the overarching goal of improving transparency and accountability, the European Medicines Agency (EMA) has been taking a more comprehensive approach to pharmacovigilance, introducing a set of good pharmacovigilance practice (GVP) guidelines to the European market.


Integral to the GVP guidelines was theintroduction of the pharmacovigilance system master file, or PSMF, which is a detailed description of the pharmacovigilance system used by the marketing authorization holder (MAH) with respect to the holder's authorized medicinal products. The PMSF has been required for new marketing authorization applications since July 2012; it will be optional for existing applications until July 2015. Read more.

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