medicines-medical devices-regulatory affairs
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: 27 April 2024 See updates at the end of the post. Paediatric submissions on IRIS platform imminent Please note that from 4 June 2024, the the following types of paediatric submissions must be done via IRIS. To ensure a…
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…