medicines-medical devices-regulatory affairs
Lost updated: 14 November 2023 See updates at the end of this post. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list has been updated and you can download the latest version…
Last updated: 19 October 2023 See updates at the end of the post. Clinical Trials Regulation (EU) No 536/2014 Questions and Answers The Q & A document has been updated to Version 6.6 of September 2023. You can view it…
Last updated on 26 September 2023 See updates at the end of the post. Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation The European Commission recently published guidance on the transition…
Last updated: 27 July 2023 See updates at the end of the post. Draft Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle This reflection paper provides considerations on the use of AI and Machine…
Last updated: 28 June 2023 See updates at the end of the post. Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations Revision 2 (of 27 June 2023) of the above…
Last updated: 2 June 2023 See updates at the end of the post. “Blue – Box” requirements “Blue – Box” requirements concern additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of…
Last updated 26 April 2023 See updates at the end of the post. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure This document has been updated. Here you can view track changed (Dec 2022) and clean…
Last updated: 4 April 2023 See updates at the end of the post. Q&A about the raw data proof-of concept pilot for industry In July 2022, the EMA launched a pilot project to assess whether the analysis of ‘raw data’…
Last updated: 28 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 24-26 January 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 27 February 2023 See updates at the end of the post. EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 Revision 1 of the above document dated 15 Feb…