medicines-medical devices-regulatory affairs
Last updated: 8 October 2025 To view updates, click on the ‘+’ sign below Q&A Clinic on web based electronic Application Form eAF functionalities This is a video of a Q&A Clinic webinar hosted by the EMA on 30 September…
Last updated: 30 September 2025 To view updates, click on the ‘+’ sign below: Updated PLM Portal eAF Release notes now available An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF…
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…
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…
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: 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…
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…
The EMA has launched a new pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). This pilot programme is part of EMA’s regulatory support for the expert panels on…
Last updated: 7 February 2024 See updates at the end of the post. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of…
Last updated: 1 February 2024 See updates at the end of the post. Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Here, you can view the track changed (September 2023) and clean…