15/16 September 2020
On March 24, 2017, the European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at two sites in India:
Bioequivalence studies are usually the basis for approval of generic medicines. Medicines where suitable alternative data are available can remain on market. The list of medicines recommended for suspension and the list of medicines recommended to remain on the market (where alternative supporting data have already been provided) can be found on the EMA website. The suspensions can be lifted once alternative data establishing bioequivalence are provided.
The EMA also recommends that medicines not yet authorized but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorized until bioequivalence is demonstrated using alternative data.
As reported under "Once again Critical Inspection Findings at two Indian Study Sites" the review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance 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, deficiencies in documentation, and data integrity.
The EMA says that "the review, by EMA’s Committee for Medicinal Products for Human Use (CHMP), concluded 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 evidence of harm or lack of effectiveness of medicines authorized and being evaluated in the EU on the basis of studies at the sites".
Additionally, EMA emphasizes that "some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in certain EU Member States. 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".
Furthermore, the EMA states that "the CHMP’s recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU".
Read the full press release on EMA´s recommendation for suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs.