Category CMDh updates

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…

Last updated: 14 July 2024 Click on the + sign below to see the updates to this post. ICH eCTD v4.0 package updated The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within…

Last updated: 6 June 2024 See updates at the end of the post. New Paediatric submissions are mandatory via IRIS platform from 4 June 2024 From 4 June 2024, the following types of new paediatric submissions must be submitted out via IRIS: To…

Last updated: 7 June 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 19 – 20 March 2024 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes…

Last updated: 5 March 2024 See updates at the end of the post. Q&A – Pharmacovigilance Legislation Regulation (EU) No 1235/2010 and Directive 2010/84/EU updated The above document has been updated. Here, you can view the track changed and clean…