medicines-medical devices-regulatory affairs
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 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.…
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 20 Jul 2026 Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device…
Last updated on 21 July 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…
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…
Last updated: 17 July 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: 17 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: 17 July 2026 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
Health Canada is encouraging the introduction of new drugs (therapies, treatments, and medicines) to Canada by modernising its regulatory review process. This is being done in a number of ways as follows: Pharmaceutical and Life Sciences Task Force Ministerial Reliance…
Last updated: 15 July 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…
Last updated: 14 July 2025 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 2 July 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…