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The European Medicines Agency (EMA) said the suspension was ordered for all drugs for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Comment from Micro Therapeutic Research Labs could not be obtained.
Micro Therapeutic Research Labs is a contract research organization (CRO) that performs analyzes and clinical parts of bioequivalence studies, some of which are used to support applications for authorization to place medicines on the market in the EU.
"The study conducted by the Committee for Medicinal Products for Human Use (CHMP) of the EMA concluded that the data from the studies carried out at both sites between June 2012 and June 2016 are unreliable and can not be accepted as a basis for The marketing authorization in the EU, "EMA said in a statement. However, it stated that there was no evidence of damage or ineffectiveness of medicinal products authorized and evaluated in the EU on the basis of studies carried out.
Aurobindo Pharma, Zydus, Sandoz, Sanofi and Mylan are among the leading pharmaceutical companies that will be affected by the suspension.
The review of the drugs studied by Micro Therapeutic Research Labs began after inspections to verify compliance with good clinical practice by the Austrian and Dutch authorities in February 2016, the EMA said.
"The CHMP recommendation on these drugs will now be sent to the European Commission for a legally binding decision valid throughout the EU," the EMA said. "The inspections revealed several concerns about the company's sites regarding the misrepresentation of study data and the lack of documentation and data management," it added.
However, the regulatory body has stated that some of the medicines that have been recommended for suspension may be of critical importance in some EU Member States. Therefore, the national authorities may temporarily postpone the suspension in the interests of patients.
"Member States should also decide whether recalls of the medicines concerned are needed on their territory," the EMA said.
