EMA has published the revised version of its policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management…

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.…, “EMA welcomes the new HTA regulation and is ready to do what it […]

EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and…

We are getting closer to the end of another year – usually this time gets very busy for everyone, as we still have goals, deadlines, and ambitious plans for what we want to…, This is good news for patients, but also a very encouraging indication […]

EMA’s office is closed from 18:00 on Thursday 19 December 2024 to 08:30 on Monday 6 January 2025.Outside of working hours and on public holidays, it is possible to call the…

The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot found that the EU…