BRUSSELS, March 24 (Xinhua) -- The European Medicines Agency (EMA) said on Friday that it had recommended suspending a number of medicines due to unreliable bioequivalence studies.
According to the EMA, the bioequivalence studies, usually the basis for approval of generic medicines, were conducted by Micro Therapeutic Research Labs at two sites in India.
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended that several medicines remain on the market because alternative supporting data had already been provided for them.
However, there was currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Micro Therapeutic Research Labs, said EMA.
Micro Therapeutic Research Labs is a contract research organisation which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the European Union (EU).
The CHMP's review of the studies conducted by the lab was started on Dec. 15, 2016 to check compliance with good clinical practice. The review found there were several concerns regarding misrepresentation of study data and deficiencies in documentation and data handling, said EMA.
The review was carried out by CHMP and concluded that data from studies conducted at the sites between June 2012 and June 2016 were unreliable and could not be accepted as a basis for marketing authorisation in the bloc.
The CHMP's recommendation will now be forwarded to the European Commission, which will issue a final legally-binding decision applicable in all EU member states.
