EU acts over data doubts

Published: 6-May-2015

Doubts cast over data forming part of bioequivalence trials carried out by Indian company GVK Biosciences led to a re-examination of EU market authorisations involving clinical trials carried out by the CRO in Hyderabad. A recent European Parliament hearing examined whether the action was justified

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The re-examination of EU market authorisations following concerns over clinical trials conducted by GVK Biosciences in Hyderabad, India, has sparked intense debate in Brussels. A European Parliament hearing has heard comment and details about the recommendation from the European Medicine Agency’s committee for medicinal products for human use (CHMP) that some 800 forms and dosages of medicines approved in the EU be suspended. All approvals were based on clinical trials conducted by the Hyderabad branch of the Indian contract research organisation (CRO).

German MEP Peter Liese, who initiated the debate at the Parliament’s environment, public health and food safety committee, asked: ‘Why do we have clinical trials? If they are not done properly and there are no consequences, that raises the question of why we are carrying out these trials at all.’

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