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EMA Suspends 136 Drugs Over Flawed Bioequivalence Studies

July 28, 2016

The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India.

Medicines for which bioequivalence studies were conducted at Semler are under scrutiny after an inspection of the research site found “substitution and manipulation” of study samples, EMA stated in a report. The World Health Organization found data integrity issues and manipulation of study samples during its inspection Semler’s bioanalytical and clinical sites.

The potentially suspended generic medicines affect manufacturers ranging from Sandoz and Teva to Mylan and Lupin.

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