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German Regulator Hails EMA's Generic Drugs Suspension on GVK Bio Data

by Vishnuprasad on Jan 27 2015 3:46 PM

German Regulator Hails EMA
German drug regulator has hailed the European Medicine Agency's decision to suspend the marketing authorisation of more than 700 generic drugs subjected to clinical trials by India's GVK Biosciences.
The decision is being seen as the EU's determination to maintain high ethical and medical standards for approval of medicines.

The EU drug regulator's announcement is also an endorsement of the Federal Institute for Drugs and Medical Devices' (BfArM) decision last month to ban the sale of 80 generic drugs on account of ‘substantial deficiencies’ in clinical trials.

The German watchdog said it would take a decision shortly on whether to add more medicines to the list of banned drugs in the wake of the EMA's announcement.

The agency based in Bonn had so far reviewed the marketing approvals of 176 generic drugs granted on the basis of clinical trial data provided by GVK Biosciences during the period between 2008 and 2014, the agency said in a statement.

The EU drug regulator on Friday suspended the marketing authorisation of around 700 generic drugs on the grounds that their approvals were supported by ‘flawed’ clinical trial data provided by the Indian company.



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