Category European Union

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

Image with TIME FOR TEXT written on it

Last updated: 11 December 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…

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

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

Last updated: 11 December 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…

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

Progress with amendments to the EU variations regulation and guidelines

Last updated: 4 December 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…

Read MoreProgress with amendments to the EU variations regulation and guidelines

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…

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

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

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 –…

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

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…

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