Start of referral: Micro Therapeutics Research Labs, India [GxP / QC / QA]

posted by Dr_Dan  – Germany, 2016-12-20 10:33 (2970 d 22:16 ago) – Posting: # 16862
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Dear all
The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union.
Does anybody have an idea which were the findings that lead to this decision?


Edit: Category changed. [Helmut]

Kind regards and have a nice day
Dr_Dan

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