Europe moves ahead with unified approach to Phase IV monitoring

6 April 2017

For the last two years, the European Medicines Agency has carried out ‘single assessments’ of post-marketing safety reports relating to products with the same active substance.

Previously, such reports had been submitted by drugmakers and reviewed separately.

The EMA has now issued drugmakers with additional guidance and recommendations related to this approach, which is designed to streamline the pharmacovigilance process for generics and biosimilars.

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