EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorizations of several generic medicines tested by Synchron Research Services, a contract research organization (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.
“For the majority (around 100 medicines) no adequate bioequivalence data were available from other sources.”
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.
“The majority of medicines that were being evaluated for authorization on the basis of data from Synchron Research Services will not be granted authorization in the EU.”
To lift the suspension, companies relying on data from Synchron Research Services must provide alternative data demonstrating bioequivalence. For a small number of authorized 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 authorization on the basis of data from Synchron Research Services will not be granted authorization in the EU.
A legally binding decision
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.
The CHMP’s recommendation will now be sent to the European Commission which will issue a legally binding decision in due course.
More about the medicines
The review covered generic medicines authorised or being evaluated via national procedures on the basis of studies conducted by Synchron Research Services, located in Ahmedabad, India on behalf of marketing authorisation holders. The medicines were authorised or being evaluated for approval in several EU Member States.
See details of the concerned medicines.
Source: The EMA