medicines-medical devices-regulatory affairs
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 2 Sep 2026 Evaluation of Therapeutic Equivalence This guidance provides information regarding FDA’s therapeutic equivalence…
Last updated: 23 September 2026 To view updates, click on the ‘+’ sign below. Updated PLM Portal eAF Release notes now available An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF…
Last updated: 20 August 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
Date Event Further information 16 Dec 2025 The EU commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices The details of the Commission Proposal are discussed in this post1. 1 July 2026…
Last updated: 13 August 2026 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
Last updated: 7 August 2026 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots, search engines and other AI based software. Chatbot/search engine Company…
Last updated: 5 August 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in an easy to understand…
Last updated: 30 July 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. Legal Framework The table below provides inforation on the…
Last updated on 30 July 2026 To view updates, click on the ‘+’ sign below. Templates variation assessment report Here, you can view the track changed (Mar 2026) and clean (Jul 2026) versions of the document Type II variation Preliminary-Final…
Last updated: 27 July 2026 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
Last updated: 26.07.26 To see updates, click on the ‘+’ sign below. This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is by no…
This post is an attempt to provide salient information on Case C-794/25 Referring court Østre Landsret, Denmark (High Court of Eastern Denmark) Parties to the main proceedings1 Applicant/Appellant: Stada Arzneimittel AG Defendant/Respondent: Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceutical Company Ltd. Product concerned1…