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The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
The European Medicines Agency (EMA) announced on March 24, 2017 that it was recommending the suspension of approved drugs and delaying the approval of drugs under review for which bioequivalence studies were conducted by Micro Therapeutic Research Labs. The suspension is because the agency has determined that the bioequivalence data produced by Micro Therapeutic Research Labs is unreliable. EMA stated in a press release that the suspension may be lifted once alternative bioequivalence data are obtained. The suspension recommendation has been sent to the European Commission for a “legally binding decision valid throughout the European Union,” according to EMA.
Micro Therapeutic Research Labs, a contract research organization, conducts analytical and clinical parts of bioequivalence studies. Studies conducted by the company have been under review following an inspection of the company by Austrian and Dutch authorities in February 2016, when inspectors found misrepresentation of study data and deficiencies in documentation and data handling. EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that data from studies conducted by Micro Therapeutic Research Labs between June 2016 and June 2016 were “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,” according to a press release.
A list of drugs affected by the suspension, which include medicines by a number of manufacturers including Sandoz, can be found on EMA’s website. A list of medicines for which the agency has already received additional data and, therefore, are not suspended can also be found on the agency’s website. EU member states that determine that a suspended drug is of critical importance may temporarily postpone the suspension.