EMA Upholds GVK Biosciences Suspension Recommendation

The European Medicines Agency (EMA) has confirmed its recommendation to suspend medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India, following a re-examination requested by marketing authorization holders for seven of the medicines recommended for suspension.

EMA’s Committee for Medicinal Products for Human Use (CHMP) had adopted a recommendation in January 2015 following an inspection of GVK Biosciences’ site at Hyderabad by the French medicines agency (ANSM) that revealed data manipulations of electrocardiograms during the conduct of studies of generic medicines, which appeared to have taken place over a period of at least five years, The systematic nature, extended period of time during which they took place and the number of GVK Biosciences staff members involved cast doubt on the integrity of the conduct of trials at the site and on the reliability of data generated, EMA reports in a statement.

In its re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available. One medicine included in the re-examination, for which concerns about studies were addressed, is no longer recommended for suspension.

As a result of the CHMP’s January 2015 opinion and the re-examination, approximately 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension. For approximately 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.

The CHMP noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad. Some of these medicines may remain on the market in some countries if they are of critical importance for patients because alternatives cannot meet patients’ needs. The national authority of each EU member state determines whether a medicine is critical for patients.

The CHMP’s recommendation will be sent to the European Commission for a legally binding decision, which will apply to all member states irrespective of whether or not they have suspended the medicines.

A list of medicines for which the CHMP recommends suspension is available on the EMA website.

Source: European Medicines Agency