Four European countries have decided to suspend marketing authorisations of 25 drugs, which had undergone...
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.
European Medicines Agency (EMA) said in a statement that it is 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on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU.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.
EMA started the review in September 2014 following an inspection carried out by the French medicines agency at the GVK Biosciences, which raised concerns about `reliability of studies’ conducted at the facility between 2008 and 2014.
EMA’s Committee for Medicinal Products for Human Use (CHMP) is now identifying, together with member states of the EU, the medicines covered by the inspection findings.
French drug regulator ANSM said on its website that Belgium, Germany, Luxembourg and France decided to suspend the marketing authorisations for the medicinal products concerned.
“Although these documents (with regard to alleged irregularities) are not essential to the demonstration of bioequivalence, the ANSM decided, as a precaution, to suspend the marketing authorisation of 25 marketed generic drugs.
“This decision is taken as a precaution. No evidence has, to date, led to establish a proven risk to human health or lack of effectiveness of these drugs….these drugs are available in other brands,” the French regulator said.