medicines-medical devices-regulatory affairs
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 Clinical Trials) is a pilot initiative bythe Heads of Medicines Agencies (HMA), the…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
Last updated: 21 January 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…
What is the OPEN framework? The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities). Brief history of the OPEN framework Date Event Dec…
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: 20 January 2026 To view updates, click on the ‘+’ sign below: On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective…
Last updated: 13 January 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…
Date Title of guidance and link to document Type and levelof guidance About the guidance 12 Jan 2026 Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products Draft This document provides guidance to sponsors and applicants submitting…
This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory Authority (the ANSM) and Eli Lilly. Specifically, it concerns the opinion of Attorney General…
Last updated: 9 January 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. In summary: The commission delegated regulation (EU) 2024/1701 Timeline…
Last updated: 8 January 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: 7 January 2026 To view updates, click on the ‘+’ sign below. The worksharing procedure for the assessment of Active Substance Master File (ASMF) The document with the above title has been updated. Here, you can view the…