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.

The CHMP adopted its initial recommendation in May 2022, 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 releases the same amount of active substance in the body as the reference medicine.

The CHMP concluded that for the majority of the medicines investigated no adequate bioequivalence data were available from other sources and therefore recommended that they be suspended. For a small number of authorised generic medicines, adequate bioequivalence data were available from other sources, and these medicines were allowed to remain on the EU market.

During the re-examination, the CHMP identified that adequate bioequivalence data are available from an alternative study for eight medicines. The marketing authorisations for these medicines can therefore be maintained.

As a result of the CHMP’s initial opinion and re-examination, the recommendation to suspend around 100 medicines for which adequate bioequivalence data are lacking is confirmed. To lift the suspension, companies must provide alternative data demonstrating bioequivalence. Medicines for which ongoing marketing authorisation applications rely solely on data from Synchron Research Services will not be granted authorisation in the EU. An updated list of the medicines concerned by the procedure is available on the EMA website.

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 and national authorities can therefore 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.

Published on: 21 September 2022