Category European Union

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

Last updated: 2 April 2026 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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A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

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Last updated: 9 March 2026 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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Amendments to the EU variations regulation and new variations guidelines

EU Variations update

Last updated: 4 March 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. Legal Framework What are some of the changes introduced…

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FAST-EU, a pilot initiative that enables an accelerated assessment of multinational clinical trials in the European Union

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…

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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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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…

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