EMA Suspends Drugs Due to Flawed Bioequivalence Studies

On July 22, 2016, the European Medicines Agency (EMA) recommended the suspension of approved medicines, and the non-authorization of drugs currently under evaluation, for which bioequivalence studies were performed at Semler Research Centre Private, Ltd., Bangalore, India. The suspension follows an EMA review and an FDA inspection of the India facility that revealed substitution and manipulation of clinical samples. The World Health Organization also found data integrity issues and manipulation of study samples during their inspection.

EMA stated, in a press release, that European Union Member States could temporarily postpone the suspension if the affected medicines are of critical importance. A list of affected medicines can be found on EMA’s website. Alternative studies were performed on some drugs, and EMA determined that these drugs could remain on the market.

“The findings from FDA and WHO inspections call into question the quality management system in place at Semler, and thus on the reliability of the data of all bioequivalencestudies, including those used to support marketing authorization applications in the EU. EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the studies conducted at Semler cannot be accepted in marketing authorization applications in the EU. Thus, no medicines can be approved on the basis of these studies,” EMA said in the press release.

Source: EMA