MHRA License Suspensions

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] MHRA has suspended licenses for about 700 non-critical generic drugs for which authorization was based on clinical studies conducted at GVK Biosciences’ site in Hyderabad, India. Licenses for those that are deemed critical to continuity of supply in the EU have not been suspended. The action was supported by the European Commission based on findings from a 2014 French medicines agency (ANSM) inspection of the facility that “cast doubt on the way clinical trials were performed at the site and therefore the reliability of bioequivalency data used to support the granting of a medicine’s license.” However, MHRA noted, “there is no evidence that these medicines are unsafe and people should continue to take them.” In response to the license suspensions, the Indian government has delayed free trade agreement talks scheduled with the EU, the Economic Times of India reported.
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