medicines-medical devices-regulatory affairs
Last updated: 13 March 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: 9 March 2026 To view updates, please click on the ‘+’ sign below: Date Update(s) to the position paper 9 Mar 2026 The Annexes have been revised to reflect the updated recommendation paper of the European Commission’s Directorate-General…
Last updated: 13 February 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…
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 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…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) published Version 1.0 of the recommendation paper on decentralised elements in clinical trials on 14 December 2022. It was updated in October 2025 (Version 2) . The…
Last updated on 9 July 2025 See history of updates below. This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on…
Last updated: 1 July 2025 To view updates, click on the link below: Switzerland is considered a leading research locations for clinical trials. What is at the core of the fast-track procedure? At the core of the fast-track procedure will…
Last updated: 27 June 2025 To view updates, click on the ‘+’ sign below. What is COMBINE? COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research. When did the COMBINE Project 1 –…
The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations. This webinar details the upcoming implementation of new clinical trial regulations in the UK. How you might use…