EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

The EMA has recommended the suspension of the marketing authorizations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.

The recommendation follows a good clinical practice (GCP) inspection which showed irregularities in study data / inadequacies in study documentation and in the computer systems and procedures to appropriately manage study data. This raised serious concerns about the data validity and reliability from bioequivalence studies conducted at the CRO. To reach its conclusion for the over 400 medicines tested by Synapse Labs on behalf of EU companies, EMA’s human medicines committee (CHMP) looked at all available information, including bioequivalence data potentially available from other sources. A list of the medicines concerned is available on the EMA website.

For around 35 of the medicinal products concerned, sufficient supporting data were available to demonstrate bioequivalence. Thus, the marketing authorizations for these medicines will be maintained and ongoing marketing applications can continue.

For all other medicines, supporting data were lacking or insufficient to show bioequivalence and the CHMP therefore recommended suspending their marketing authorizations. To lift the suspension, companies must provide alternative data demonstrating bioequivalence. Medicines for which ongoing marketing authorization applications rely only on data from Synapse Labs will not be granted EU authorization.

Some of the medicinal products that have been recommended for suspension may be of critical importance (e.g., due to lack of available alternatives) in some EU Member States. Therefore, national authorities will assess the situation and can postpone the suspension of these medicines for a maximum of 2 years in the interest of patients. However, companies have to submit the required bioequivalence data for these medicines within 1 year.

More information is available in Synapse Labs Pvt. Ltd: EMA recommends suspension of medicines over flawed studies.

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