CHMP Recommends Suspension of Marketing Authorizations Due to Flawed Bioequivalence Studies
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommends suspending marketing authorizations for medicines based on deficient bioequivalence studies from GVK Biosciences.
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended the suspension of marketing authorizations for approximately 1,000 medicines due to deficient bioequivalence studies conducted by the Indian company GVK Biosciences. This decision stems from an inspection by the French Medicines Agency at GVK Biosciences in India, which identified significant deficiencies in study conduct and data validity, particularly concerning ECG data.
The German Federal Institute for Drugs and Medical Devices (BfArM) had already ordered the suspension of marketing authorizations for numerous German medicines on December 8, 2014, citing invalid study data. The CHMP's review has encompassed around 1,000 authorizations across EU member states. A list of affected medicines has been published online, including additional names compared to previous BfArM lists.
The European procedure is not yet concluded, as affected pharmaceutical companies have the option to request a re-examination. BfArM will make decisions on further suspensions based on the CHMP's current recommendation and the final decision from the European Commission. However, the agency emphasizes that there are currently no indications of health risks.
ABDA, representing German pharmacists, issued this information on January 23, 2015. The organization is monitoring the situation and will report on any developments that may require specific actions from pharmacies.