WHO Nods 33 National and Regional Regulatory Authorities For Medical Products

WHO has accepted the designation of 33 national and regional regulatory agencies as WHO Listed agencies (WLAs), which can be depended on to meet the highest level of regulatory standards and practices for the quality, safety, and efficacy of drugs and vaccines. This listing brings the overall number of regulatory authorities from 34 Member States recognized as WLAs to 36 since the initiative's start in March 2022.

The European Medicines Agency (EMA), the European Commission, the European Medicines Agency (BLA), and the medicine regulatory bodies of the following 30 nations comprise the newly approved WLAs: Germany (Paul-Ehrlich-Institut & Federal Institute for Drugs and Medical Devices), Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

“Today marks a significant progress in our collective efforts to improve access to safe, quality and effective medicines and vaccines. With leading regulatory authorities joining our list, we are stronger and more united to improve access to quality, safe and effective medicines and vaccines for millions more people,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “I would like to congratulate all agencies designated as WLAs for their investment and commitment to the quality and safety of medicines and vaccines. My thanks also to our experts for their diligent work to implement a transparent and evidence-based assessment throughout the evaluation process”.