Human medicines in 2024
In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these…
New EU rules for health technology assessments become effective
EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025.The regulation is an…
A common EU approach to data transparency in medicine regulation
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications…
EMA Management Board: highlights of December 2024 meeting
Work programme for 2025The Management Board adopted EMA’s work programme for 2025, which outlines how the Agency will adapt to the rapidly evolving medicines landscape and prepare for the transition…
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024
Seventeen new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the total number of medicines recommended for approval…
