27-29 February 2024
Repeatedly, inspections of study centers in India have found significant deficiencies in the conduct of bioequivalence studies. As a result, the European Medicines Agency (EMA) has initiated a review of medicines for which studies were conducted by Synapse Labs Pvt. Ltd, a contract research organization (CRO) based in Kharadi, India. This followed a Good Clinical Practice (GCP) inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.
Synapse Labs was subject to a GCP inspection in November 2020 and November 2022 by the Spanish competent authority where critical findings were identified that cast serious doubts on the reliability of the analytical and clinical data generated by the CRO. The severity and the extent of the findings of the inspection raised serious concerns relating to the suitability of the quality management system (QMS) at Synapse Labs Pvt. Ltd. and about the overall reliability and the quality of data (both clinical and analytical) submitted to support marketing authorizations for medicinal products in the EU. Amongst others, the findings included significant deficiencies in the following areas:
After reviewing the results of the GCP inspection, the Spanish Medicines Agency requested EMA's Committee for Medicinal Products for Human Use (CHMP) to assess the impact on the benefits and risks of medicines approved on the basis of studies conducted at Synapse Labs' facilities. The agency was also asked to assess the impact on medicines currently under review for approval based on trial data generated at the CRO.
The EMA will now review the available data to determine whether action is needed to protect public health. The opinion is then forwarded to the European Commission, which makes a final, legally binding decision that applies in all EU member states.
There is a possibility that the national competent authorities will once again declare the suspension of marketing authorizations related to clinical trials, in particular bioequivalence trials, conducted by these study centers in India. Thus, affected companies should already review their data situation and - if necessary - take appropriate action in a timely manner.
Further information and details, such as list of all affected products, can be found on the EMA website.