The European Medicines Agency (EMA) has suggested suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for consent of generic medicines. The list of medicines suggested for check can be found here. The deferrals can be lifted once alternative data establishing bioequivalence are provided.
Substitute supporting data have already been provided for several of the medicines studied. Therefore, the CHMP suggested that these medicines can remain on the market. The list of medicines recommended to remain on the market is available here.
The Agency also endorsed that medicines not yet authorized but which are being assessed on the basis of bioequivalence studies from these sites should not be authorized until bioequivalence is verified using alternative data.
Micro Therapeutic Research Labs is a contract research organization (CRO) which conducts the diagnostic and clinical parts of bioequivalence studies, some of which are used to support marketing authorization applications of medicines in the EU.
The review of medicines studied by Micro Therapeutic Research Labs was started after reviews to check amenability with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling.
The review, by EMA’s Committee for Medicinal Products for Human Use (CHMP), determined that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorization in the EU. However, there is no indication of harm or lack of efficiency of medicines authorized and being assessed in the EU on the basis of studies at the sites.
Some of the medicines which have been suggested for deferral may be of critical importance in certain EU Member States. The CHMP’s approval concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.
Date: 24th March 2017