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.

The recommendation comes after irregularities were found in how the CRO carried out bioequivalence studies, which raised serious concerns about the company’s quality management system and the reliability of data from that site. Bioequivalence studies are conducted to show that a generic medicine release the same amount of active substance in the body as the reference medicine.

The CHMP looked at all medicines tested by Synchron Research Services on behalf of EU companies and found that for the majority (around 100 medicines) no adequate bioequivalence data were available from other sources. The Committee recommended that these medicines be suspended. To lift the suspension, companies relying on data from Synchron Research Services must provide alternative data demonstrating bioequivalence. For a small number of authorised generic medicines (around 20), adequate bioequivalence data were available from other sources, and these medicines are allowed to remain on the EU market.

With just a couple of exceptions for which data from other sources are available, the majority of medicines that were being evaluated for authorisation on the basis of data from Synchron Research Services will not be granted authorisation in the EU.

The list of concerned medicines can be found in the list of medicines concerned by the procedure ("Related links").

Some of the medicines that have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories.

EMA and national authorities will continue working closely together to ensure that studies on EU medicines are carried out to the highest standards and that companies comply with all aspects of good clinical practice (GCP). If companies do not meet required standards, authorities will take whatever measures necessary to ensure the integrity of data used to approve EU medicines.
The CHMP's recommendation will now be sent to the European Commission which will issue a legally binding decision in due course.