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Focus On Regulation

Insights, analysis, and news about regulatory issues affecting a broad array of industries.

Blog Post

EMA post-authorisation procedural advice for users of the centralised procedure

24 January 17

On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...

Blog Post

EMA Update concerning EU Clinical Trials portal and database

24 January 17

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...

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