EMA to Re-Examine Suspensions from GVK Biosciences Site


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-03-2015 08:05

  

Following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to suspend marketing authorizations of a number of medicines for which authorizations were primarily based on clinical studies conducted at GVK Biosciences, some marketing authorization holders have requested a re-examination. Once the grounds for re-examination are received by the EMA from these marketing authorization holders (the deadline is March 30, 2015), the CHMP will start a re-examination. The re-examination will conclude within 60 days.

In January 2015, the CHMP recommended suspending a number of medicines that had been granted marketing authorization in the European Union (EU) that were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The recommendation was based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders. The CHMP looked at more than 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site. For over 300 of them, sufficient supporting data from other sources were available; these will remain on the market in the EU as EMA is satisfied with the available data. For medicines that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences, said the EMA when it issued the recommendation in January.

The inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM). "The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines," said the EMA in a statement in January 2015. "These manipulations appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place, and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site."

Source: European Medicines Agency

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