medicines-medical devices-regulatory affairs
PLM Portal eAF – January 2026 final version now available The final “January 2026” version containing the new human variation classification, entering into force on 15 January 2026, is now available on the PLM Portal eAF. Note: The z-scopes are…
Date Title of guidance and link to document Type and levelof guidance About the guidance 2 Dec 2025 Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Draft The purpose of this guidance is to assist sponsors in implementing streamlined approaches for nonclinical…
Last updated: 3 December 2025 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: 1 December 2025 To view updates, click on the ‘+’ sign below. Highlights from the Clinical Trials Coordination Group (CTCG) plenary meeting On 3–4 November 2025, CTCG met at EMA to discuss initiatives aimed at streamlining clinical trial…
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.…
On 27 November 2025, a large number of National Competent Authorities (NCAs) and Ethics Committees committed to test a coordinated fast-track approach for evaluating multinational clinical trials. About the FAST-EU (Facilitating and Accelerating Strategic Trials) initiative When is the FAST-EU…
The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (referred to in Article 34(1) of Regulation (EU) 2017/745) declaring the…
The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536 These updates, published on…
Last updated: 29 November 2025 See history of updates below This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign…
Last updated: 6 November 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. The commission delegated regulation (EU) 2024/1701 Timeline of…
Last updated: 18 November 2025 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: 30 October 2025 To view updates, please click on the ‘+’ sign below: Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products to Version 3.3 of 27 October 2025. Unfortunately, no information has…