Latvian.pdf

The French Agency on medicinal products (ANSM) inspected GVK Biosciences Private Limited in India from 19-23 May 2014 and found data manipulations of electrocardiograms (ECGs) in all 9 trials inspected, casting doubts on the authenticity of clinical records. The European Commission initiated a referral to assess the impact on the benefit-risk balance of products authorized based on studies conducted at the site. The CHMP concluded that all bioequivalence studies with clinical activities carried out at the site since 2004 are unreliable to support the benefit-risk balance of medicinal products. MAHs were requested to submit data to prove bioequivalence, and discussions took place on the classification of responses into three categories. The CHMP considered that the bioequivalence is not established, and safety and efficacy cannot be extrapolated, leading to a non-positive benefit-risk balance. Audits and inspections with positive outcomes at the site were not considered sufficient to rely on bioequivalence studies, and pharmacovigilance data did not provide reassurance. The CHMP concluded that studies cannot be relied upon to establish bioequivalence vis-à-vis the EU reference medicinal product.