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 by the Heads of Medicines Agencies (HMA),…
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…
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…
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 –…
Last updated: 12 January 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…
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…
AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines. In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for…