Initiated review of studies conducted by Synapse Labs Pvt. Ltd (India)
The European Medicines Agency (EMA) has started a review of medicines whose clinical trials of 
bioequivalence were conducted by Synapse Labs Pvt. Ltd, a contract research organization (CRO, Contract Research Organisation) based in Kharadi (India). This review follows a good clinical practice (GCP) inspection carried out by the Spanish Medicines and Medical Devices Agency (AEMPS) which raised serious concerns about the validity and reliability of the data generated at the CRO.
In the light of the results of the GCP inspection, the Spanish Agency asked EMA's Committee for Medicinal Products for Human Use (CHMP) to assess the impact on the benefits and risks of medicines authorized based on studies conducted at Synapse Labs . EMA has also been asked to look into the impact on medicines currently under evaluation that use study data generated at the CRO.
EMA will examine the available data to determine whether measures are needed to protect public health.
The review concerns generic medicines authorized or under evaluation under national, mutual recognition or decentralized procedures, which are based on studies conducted by Synapse Labs Pvt. Ltd (India), on behalf of marketing authorization holders trade or applicants.
The review was initiated at the request of the Spanish Regulatory Agency under Article 31 of Directive 2001/83/EC.
The review is being conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions relating to medicinal products for human use, which will adopt the EMA opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
