 "EU members fault GVK Bio clinical trials, suspend marketing approvals for medicines")
According to the European Medicines Agency (EMA), some of the member states have decided to suspend the marketing authorisations of medicines that have been authorised on the basis of studies conducted at India’s GVK Biosciences site in Hyderabad. As per a Reuters report, drug regulators in France, Germany, Belgium and Luxembourg have decided to suspend the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by GVK Biosciences.
EMA has announced that it is currently reviewing findings of non-compliance with good clinical practice at the GVK site and determining their impact on medicines authorised on the basis of studies performed at the site. These suspensions taken at national level are precautionary measures until the review is finalised, said EMA in a press release.
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on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015.
EMA has announced that it is currently reviewing findings of non-compliance with good clinical practice at the GVK site and determining their impact on medicines authorised on the basis of studies performed at the site. These suspensions taken at national level are precautionary measures until the review is finalised, said EMA in a press release.
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 authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015.