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Another Indian CRO Under EMA Lens Over Dirty Data Concerns

 
• By Anju Ghangurde

Micro Therapeutic Research Labs is now under the scanner over alleged data integrity concerns. European Medicines Agency (EMA) is evaluating medicines based on studies done by the Indian firm.

Dirty hands

Indian contract research organizations continue to face regulatory scrutiny amid concerns over dirty data. The European Medicines Agency’s scientific committee, the CHMP, has now initiated a review of certain medicines for which studies were done by Micro Therapeutic Research Labs at its sites in Chennai and Coimbatore in India.

The review covers Mylan NV’s tadalafil, authorized centrally through the EMA, as well as drugs authorized by national procedures in individual EU member states, whose marketing authorization applications included...

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