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 7 Aug 2026 M11 Clinical Electronic Structured Harmonised Protocol The purpose of this guidance is…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
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: 5 August 2026 To view updates, click on the ‘+’ sign below. Human MAA eAF v1.28.0.0 – minor version available Minor version 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application is available…
Last updated: 3 August 2026 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
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…
Date Guidance No About the guidance July 2026 MDCG 2026-5 MDCG Position Paper: UDI assignment betweenmanufacturers and distributors This MDCG Position Paper aims at explaining the point to clarify the situation and avoid confusion, misunderstandings or potential misuse arising from…
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…