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EU members fault GVK Bio clinical trials, suspend marketing approvals for medicines

European Medicines Agency (EMA) is currently reviewing findings of non-compliance with good clinical practice at the GVK Biosciences' Hyderabad site

BS B2B Bureau  |  Hyderabad 

GVK Biosciences' office

According to the European Agency (EMA), some of the member states have decided to suspend the marketing authorisations of that have been authorised on the basis of studies conducted at India’s 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 conducted by
 
has announced that it is currently reviewing findings of non-compliance with good clinical practice at the GVK site and determining their impact on 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 in a press release.
 
started the review in September 2014 following an inspection carried out by the French agency at the 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 (EU), which 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.
 
will issue a recommendation on whether the marketing authorisations of the concerned should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015.

First Published: Sat, December 06 2014. 12:22 IST
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EU members fault GVK Bio clinical trials, suspend marketing approvals for medicines

European Medicines Agency (EMA) is currently reviewing findings of non-compliance with good clinical practice at the GVK Biosciences' Hyderabad site

European Medicines Agency (EMA) is currently reviewing findings of non-compliance with good clinical practice at the GVK Biosciences' Hyderabad site According to the European Agency (EMA), some of the member states have decided to suspend the marketing authorisations of that have been authorised on the basis of studies conducted at India’s 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 conducted by
 
has announced that it is currently reviewing findings of non-compliance with good clinical practice at the GVK site and determining their impact on 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 in a press release.
 
started the review in September 2014 following an inspection carried out by the French agency at the 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 (EU), which 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.
 
will issue a recommendation on whether the marketing authorisations of the concerned should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015.
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EU members fault GVK Bio clinical trials, suspend marketing approvals for medicines

European Medicines Agency (EMA) is currently reviewing findings of non-compliance with good clinical practice at the GVK Biosciences' Hyderabad site

According to the European Agency (EMA), some of the member states have decided to suspend the marketing authorisations of that have been authorised on the basis of studies conducted at India’s 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 conducted by
 
has announced that it is currently reviewing findings of non-compliance with good clinical practice at the GVK site and determining their impact on 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 in a press release.
 
started the review in September 2014 following an inspection carried out by the French agency at the 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 (EU), which 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.
 
will issue a recommendation on whether the marketing authorisations of the concerned should be maintained, varied, suspended or withdrawn across the EU. The recommendation is expected in January 2015.

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Business Standard
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