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.
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...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
