Category European Commission

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

Last updated: 10 July 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

Progress with amendments to the EU variations regulation and guidelines

Last updated: 3 July 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 Timeline of events leading…

Read MoreProgress with amendments to the EU variations regulation and guidelines

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

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: 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…

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: 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…

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

European Commission initiative on compulsory licensing of patented inventions and Supplementary Protection Certificates

Last updated: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…

Read MoreEuropean Commission initiative on compulsory licensing of patented inventions and Supplementary Protection Certificates