Wednesday, 08 July 2020

GVK's drug studies suspended by 4 EU countries

09 December 2014 | News | By BioSpectrum Bureau

GVK's drug studies suspended by 4 EU countries

(Photo Courtesy: www.emcdda.europa.eu)

(Photo Courtesy: www.emcdda.europa.eu)

The 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 which 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 Member States of the European Union (EU), which medicines are affected by the inspection findings.

The review will provide a robust 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on whether the marketing authorizations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU.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.

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