medicines-medical devices-regulatory affairs
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…
Last updated: 1 February 2024 See updates at the end of the post. Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Here, you can view the track changed (September 2023) and clean…
Last updated: 31 January 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 12-14 December 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 21 December 2023 See updates at the end of the post. Meeting with Interested Parties – 15 November 2023 These meetings appear not to have any minutes published which would be very useful. Instead, the individual presentations from…
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…