Category CMDh updates

Last updated: 17 April 2025 To view updates, click on the ‘+’ sign below PSUSA procedures: new requirement for Word version of the PSURs and RSI responses When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation…

Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: Update – MedEthicsEU report – Survey on National Part II Clinical Trial Application (CTA) requirements (March 2025) Overview part II requirements in a Clinical Trial application…

Last updated: 5 February 2025 To view updates, click on the ‘+’ below: Minutes and presentations from the 20 November 2024 meeting with Interested Parties You can view the minutes of the meeting here and most of the presentations from…

Last updated: 3 February 2025 To view updates, click on the ‘+’ sign below. Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh  You can view the decisions here. Source: HMA Updated eAF…

Last update: 7 January 2025 To view the updates, please click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 12-14 November 2024 The reports from the CMDh meetings (also called press releases) reflect highlights/important…

Last updated: 9 December 2024 SME Info day Here is a link to the EMA webinar SME Info Day held on on 18 October 2024. Time stamps for the various sessions in the webinar are provided below. 00:00:00 Session 1:…

Last updated: 22 October 2024 Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle This reflection paper provides considerations on the use of AI/ML in the lifecycle of medicinal products, including medicinal products development, authorisation, and post-authorisation. Given…

Last updated: 23 September 2024 To view updates, click on the ‘+’ sign below. Management of rapid alerts arising from quality defects risk assessment The document with the above title was adopted on 15 June 2024 and came into forse…