Category European Union

National Competent Authorities to launch a fast-track approach for the authorisation of multinational clinical trials in the EU/EEA

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…

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Progress with amendments to the EU variations regulation and guidelines

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…

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The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms

Last updated: 26 October 2025 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…

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COMBINE programme launches a pilot coordinated assessment for clinical trials and performance studies

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 –…

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A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

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Last updated: 16 June 2025 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…

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European Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines

Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…

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EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…

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