medicines-medical devices-regulatory affairs
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…
Last updated: 8 July 2025 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
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…
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 –…
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…
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…
Last updated: 5 March 2025 To view updates, click on the ‘+’ sign below. Multi-stakeholder workshop on Pharmacogenomics In September 2024 the European Medicines Agencies Network (EMA and HMA) and the European Commission co-hosted a multi-stakeholder workshop on pharmacogenomics. The…
Last updated: 13 July 2024 To see updates to this post, click on the ‘+’ sign below. This post summarises the proposal and main events so far concerning the extension of the IVDR transition periods. Timeline of events Date Event…
Last updated: 27 April 2024 See updates at the end of the post. Paediatric submissions on IRIS platform imminent Please note that from 4 June 2024, the the following types of paediatric submissions must be done via IRIS. To ensure a…
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…