Four European countries have decided to suspend marketing authorisations of 25 drugs, which had undergone studies/tests at the GVK Biosciences facility here before they were introduced.
The European Medicines Agency (EMA) said in a statement that it was reviewing findings of non-compliance with good clinical practise at
the GVK facility and determining its impact on medicines authorised on the basis of studies performed there.
Germany, France, Luxembourg and Belgium have already decided to suspend marketing authorisations of these drugs.
“EMA will issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January,” the regulator said.
When contacted, the GVK Bio spokesperson refused to comment, saying the news was not communicated to the company.
