On 23 January 2015, the European Medicines Agency (EMA) recommended that generics medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) should be suspended.
The news follows the decision by Belgium, France, Germany and Luxembourg to suspend the marketing authorizations of 25 generics after a site inspection by the French regulatory authority (Agence nationale de sécurité du médicament et des produits de santé; ANSM) highlighted abnormalities in the electrocardiograms (ECG) registration procedures made during clinical trials conducted between 2008 and 2014 [1].
As a result of the ANSM’s findings, EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK Bio site. For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the EU as EMA is satisfied with the available data.
However, for the remaining 700 medicines that lack data from other studies, CHMP has recommended suspension ‘unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs’.
EMA admits, however, that ‘there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences’.
EMA has made this recommendation due to the ‘systematic nature’ of the abnormalities, which took place over a five-year period. This has led EMA to conclude that ‘the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site’.
Germany’s regulator, the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), has welcomed EMA’s decision, saying that it gives a clear signal of the EU’s determination to maintain high ethical and medical standards for approval of medicines.
India’s regulator, the Central Drugs Standard Control Organization (CDSCO), has set up an expert committee to probe the matter. CDSCO Deputy Drugs Controller, Mr PBN Prasad stated that ‘as per our preliminary investigations, we feel it has nothing to do with drug safety issues as alleged by various media reports’.
The CHMP’s recommendation will be sent to the European Commission for a legally binding decision. This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.
The full list of medicines for which CHMP recommends suspension is available on the EMA website at http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/01/WC500180894.pdf.
In response to the EMA decision, GVK BIO stated that it ‘is respectful of the EMA decision taken in the interest of human health’ and that it ‘is working closely with its customers to ensure an appropriate and quick resolution to these issues’.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EU Member States suspend generics approvals due to problems at CRO [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 6]. Available from: www.gabionline.net/Generics/General/EU-Member-States-suspend-generics-approvals-due-to-problems-at-CRO
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Source: Bfarm, EMA, GVK Bio
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