medicines-medical devices-regulatory affairs
Last updated: 4 August 2026 To view updates, click on the ‘+’ sign below. Guidance published by Member States on the implementation of the Falsified Medicines Directive You can view the links to the guidance here. Report from the CMDh…
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: 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…
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 30 Jul 2026 Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Final, Level…
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…
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…