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  • Regulatory NewsRegulatory News

    EMA Maintains Recommendation to Suspend Drugs for Data Integrity Issues

    The European Medicines Agency (EMA) has reconfirmed its recommendation to suspend the authorization of medicines that relied on clinical studies performed by Indian contract research organization GVK Biosciences. Background In January, EMA recommended EU member states suspend the marketing authorizations for products whose approval relied on GVK studies, citing concerns over "systemic" data manipulation alleged by the French National Agency for Medicines and Health Pr...
  • Regulatory NewsRegulatory News

    EMA Recommends Suspending Drugs over GVK Data Integrity Issues

    The European Medicines Agency (EMA) is  recommending EU Member States suspend products whose approval relied on clinical trials conducted at GVK Biosciences in Hyderabad, India. The agency cites concerns over “systemic” data manipulation alleged by the French National Agency for Medicines and Health Products Safety (ANSM) following an inspection of GVK’s site in May 2014. For more about the allegations against GVK see our December 2014 article, “ EU Regulators Conce...
  • Regulatory NewsRegulatory News

    EU Regulators Concerned About Drug Data Fraud by Indian Company

    European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. Background In September 2014, French regulator ANSM raised concerns about GVK Biosciences, saying a good clinical practice (GCP) inspection had "raised serious concerns regarding the GCP compliance of the conduct of the clinical part of bioequivalence trials" at the company's...