German drug regulators are examining whether to suspend the use of more than 100 medicines on the suspicion that
they were given marketing licences for forged medical reports of human trials
The EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio. GVK Biosciences (GVK BIO) allegedly manipulated the results of clinical trials of generic drugs it carried out on behalf of several European manufacturers, say some German media reports. Germany’s drug regulators are currently examining whether to suspend the use of more than 100 medicines on the suspicion that they were given marketing licences for forged medical reports of human trials, say TV channels NDR and WDR and the Munich daily Sueddeutsche Zeitung.
FE had reported on September 26 that GVK BIO had received a letter from the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), a European drug agency, along with France-based Agency for Medicines and Health Products Safety (ANSM), following a ‘good clinical practice’ (GCP) inspection citing deficiencies that stretch back to 2008.
French drug regulator ANSM found out during a routine control of medical reports earlier this year that GVK Bio had forged the outcome of a study of a heart drug.
In nine studies, the French authorities found partial manipulation. The EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio. The Federal Institute for Medicines and Medical Products, which issues licences in Germany, confirmed that it had been investigating the allegations against the company. The agency said it was too early to determine the exact number of medicines involved, but they may be more than 100, according to the reports.
Two drugs manufactured by the German company, Betapharm and anti-allergy medicine Fexofenadin by Hexal, are among the medicines currently being investigated.
German authorities have so far no information that the drugs involved posed any health risk for the public, the reports said. Documents with the EMA and the European Commission showed that at least 10 GVK Bio staff members were involved in the forgery, which took place between 2008 and 2013, the reports said.
When contacted, GVK Bio said in an email response that it had already submitted independent cardiology assessments of the ECGs indicating that they belonged to multiple volunteers and it was difficult to conclude that they belonged to the same volunteer. The company said an inspection team from the German drug regulatory body inspected the facility in October.
“We also provided evidence that all key activities such as dosing, blood sampling and processing were adequately controlled, supervised and the staff were qualified to do the work. We also strengthened the operating procedures around taking the ECGs and these were accepted by the authorities,’’ the company said.
“We are disappointed that despite providing detailed clarifications, unfortunately CHMP (Committee for Medicinal products for Human use) has concluded that though the ‘check-out’ ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities left an element of doubt on the bio-equivalence results. Hence, authorities have concluded that the bioequivalence (BE) studies conducted at our Hyderabad clinic are not sufficient to support marketing authorisation holders (MAHs) for the products approved. We expect that the marketing authorisation holders will need to repeat the studies in the next 12-15 months,’’ the company said.
Bioequivalence studies are used to assess the expected in-vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent, it means that they would be expected to be, for all intents and purposes, the same.
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