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Focus On Regulation

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

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...

Blog Post

UK MHRA to develop quality standards for biological medicines

20 January 17

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...

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