19.12.2022 - Notice within the graduated plan procedure (Stufenplanverfahren)

The Federal Institute for Drugs and Medical Devices (BfArM) implements the EU Commission's implementing decision of C(2022) 8819 final, dated 28.11.2022, on a national level by notice of 13 December 2022. This concludes the European risk assessment procedure according to Article 31 of Directive 2001/83/EC on marketing authorizations granted on the basis of studies conducted by Synchron Research Services, India.

08.12.2022 - European Commission final decision

Synchron Research Service: Final decision of the European Commission confirms suspension of marketing authorisations

EMA’s human medicines committee (CHMP) has confirmed its recommendation to suspend the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India. This concludes the re-examination requested by the marketing authorisation holders for some of the medicines concerned.

20.05.2022 - CHMP opinion

Synchron Research Service: suspension of medicines over flawed studies

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India.

31.01.2022 - Procedure started

EMA has started a review of medicines for which studies have been conducted by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):