Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends

pharmafile | July 25, 2016 | News story | Manufacturing and Production, Sales and Marketing |  EMA, Novartis, Teva, manufacturing, semler 

Following an FDA inspection and WHO investigation earlier this year, the European Medicines Agency (EMA) has recommended the suspension of a number of medicines that relied solely on flawed bioequivalence studies conducted at the Semler Research Centre in Bangalore, India.

Quality management protocols at Semler have been brought under scrutiny after the EMA’s review found a number of failings at the firm’s bioanalytical site, including the manipulation of clinical samples. The recommended suspension affects a range of nationally approved medicines in addition to those still pending authorisation.

The review has raised concerns for manufacturers Teva and Novartis, whose subsidiary Sandoz was implicated, with both producing antimalarial drugs affected by the findings, as well as an HIV antiviral from Sandoz. The EMA has ruled that a number of drugs will remain unaffected, thanks to their bioequivalence being established through other sources.

In a statement detailing the recommendation, the EMA stated:  “Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories.”

Read the full EMA notice here.

Matt Fellows