Category European Commission

Progress with amendments to the EU variations regulation and guidelines

Last updated: 22 September 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…

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EMA feedback to the EC request to evaluate the feasibility of alternatives to replace TiO2 in medicinal products and its possible impact on the availability of medicines

Last updated: 8 August 2025 To view updates, click on the ‘+’ sign below: The information for this post has been obtained from the report (of 1 April 2024) with the title above, published on 6 August 2025. Whilst the…

Read MoreEMA feedback to the EC request to evaluate the feasibility of alternatives to replace TiO2 in medicinal products and its possible impact on the availability of medicines

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…

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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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