EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
On 23 March 2017, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The list of medicines recommended for suspension is available. The suspensions can be lifted once alternative data establishing bioequivalence are provided.
The EMA has stressed its monitoring of CROs is location independent after raising concerns about third Indian contractor in two years.
EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Sandoz and Aurobindo are among drugmakers which will need to provide alternative bioequivalence data after the EMA recommended suspension of medicines tested by Micro Therapeutic Research Labs.
The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.
Start of a review concerning the conduct of studies at Micro Therapeutic
EU regulators uncover data-integrity concerns at Indian CRO