Welcome to the January 2025 issue

In this issue, you will find recent updates on medicines regulation as well as other news and the usual section on dedicated medicines.

EMA and the Heads of Medicines Agencies have carried out a comprehensive overhaul of guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines, reaffirming our commitment to transparency. The revised guidance is now available on our website.

The EU regulation on health technology assessment became applicable on 12 January 2025 and EMA will support its implementation, particularly in the conduct of joint clinical assessments, joint scientific consultations and horizon scanning. 

We have also published the revised versions of our policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management Board members (‘Policy 0058’). 

A pilot exploring the creation and testing of electronic product information (ePI) has found that the EU regulatory system is well prepared for ePI while there is a need for more development. Work to endorse this new practice will continue this year.

Several first treatments have been recommended for marketing authorisation: Emcitate (tiratricol) for Allan-Herndon-Dudley syndrome, and Welireg (belzutifan) for von Hippel-Lindau disease and advanced kidney cancer. EMA has also recommended extending the indication of Ofev (nintedanib) to include the fibrosing interstitial lung diseases in children and adolescents, for whom approved treatments have not existed. On the other hand, Alofisel, for the treatment of Chrohn’s disease, has been found not to be beneficial and will be withdrawn.  

I look forward to another year of fruitful collaboration and, as always, encourage you to share this newsletter with your members and networks. Your feedback and suggestions for future issues help us maintain the focus of this newsletter on what matter to you most. Please send any thoughts you have to: public-engagement@ema.europa.eu.

Juan Garcia Burgos

Head of Public and Stakeholder Engagement