EMA To Conduct Review of CRO GVK Biosciences

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-09-2014 13:27


Some European Union (EU) member states have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at the GVK Biosciences site in Hyderabad, India. The European Medicines Agency (EMA) is currently reviewing findings of non-compliance with good clinical practice at this site and determining their impact on medicines authorized on the basis of studies performed at the site. These suspensions taken at national level are precautionary measures until the review is finalized.

EMA started the review in September 2014 following an inspection carried out by the French medicines agency at the GVK Biosciences site that raised concerns about the reliability of studies conducted at the site between 2008 and 2014. As part of the review, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is identifying, together with EU member states, which medicines are affected by the inspection findings. The review will provide a scientific assessment of all data and determine the impact of the findings on the concerned medicines, enabling member states to take adequate EU-wide action to protect patients’ health.

EMA will issue a recommendation on whether the marketing authorizations of the concerned medicines should be maintained, varied, suspended,or withdrawn across the EU. The recommendation is expected in January 2015.

Source: European Medicines Agency


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