• RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • Regulatory NewsRegulatory News

    Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn

    Germany’s Federal Institute for Drugs and Medical Devices (BfArM) warned Tuesday of critical vulnerabilities in Wind River’s real-time operating system VxWorks, which is used in many medical devices, including MRI machines and patient monitors. “Medical device manufacturers using this operating system must implement risk mitigation measures based on their updated risk analysis in light of this vulnerability,” BfArM said. The warning comes as earlier this month, Armis...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Discuss Improving Treatment of Kids With Lymphoma, Leukemia (8 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Austria Pressures Healthcare Professionals, Physicians to Report Adverse Events The Austrian Federal Office for Safety in Health Care (BASG) has called on physicians and other healthcare professionals to comply with their obligations to report adverse events. BASG made the request after reviewing the number of adverse event reports it received from the groups last year...
  • 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...