Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd, India

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Kharadi, India. This follows a good clinical practice (GCP) inspection carried out by the Spanish Agency of Medicines and Medical Devices (AEMPS) which raised serious concerns about the validity and reliability of study data generated at the CRO.

Having considered the findings of the GCP inspection, the Spanish medicines agency requested EMA’s human medicines committee (CHMP) to assess the impact on the benefits and risks of medicines that were authorised on the basis of studies performed at Synapse Labs’ facilities. EMA has also been requested to look at the impact on medicines currently being evaluated for authorisation that use study data generated at the CRO.

EMA will now review the available data to determine if any action is necessary to protect public health.