medicines-medical devices-regulatory affairs
Last updated: 4 November 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…
About the pilot program The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches (namely leveraging QRIs and a new rolling review process) for accelerating first-in-human (FIH) clinical trials in the United…
Last updated: 30 September 2026 To see updates, click on the ‘+’ sign below. The MHRA has published guidance on a Phase 1, 14-day pilot programme for clinical trials. Below is an attempt to present the information in a Q&A…
The U.S. FDA today announced the final design of the Expedited Investigational New Drug (IND) Pilot. What does the pilot aim to achieve? Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug…
Last updated: 13 September 2026 To view updates, click on the ‘+’ sign below. About COMBINE In the EU, there are legal requirements for the individual authorisation processes of: Regulations clinical trials of medicinal products Regulation (EU) 536/2014 on clinical…
Last updated: 20 August 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…
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…