EMA Recommends Suspending Drugs from CRO GVK Biosciences' Site


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-23-2015 11:48

  

The European Medicines Agency issued a statement to recommend 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 is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

Upon the request of the European Commission, EMA’s Committee for Medicinal Products for Human Use (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.

The decision on whether a medicine is critical for patients lies with the national authorities of EU member states depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data. The full list of medicines for which the CHMP recommends suspension is available here.

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. "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."

The CHMP’s recommendation will be sent to the European Commission for a legally binding decision. This decision will apply to all EU member states irrespective of whether or not they have taken interim measures to suspend medicines.

Source: EMA

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