Europe – EMA Management Board: highlights of March 2024 meeting

EMA annual report 2023 

The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which had a new active substance. The Agency also recommended 14 veterinary medicines for marketing authorisation. In addition, the report gives an overview of key achievements in EMA’s three strategic areas in 2023: cancer medicines, better data to translate innovation into medicines, and transparency and communication. Publication of the report, including an interactive digital version, is planned for May 2024.

Update on the new Health Technology Assessment Regulation

The Board heard that preparations are ongoing by the European Commission, together with EU Member States, for the implementation of the new Health Technology Assessment Regulation (HTAR). EMA is contributing to these preparatory activities and is working closely with the European Commission, the Member State Coordination Group on HTA (HTACG) and its subgroups, as well as its stakeholders, including industry, healthcare professionals, patients and academia…