Category European Medicines Agency

Progress with amendments to the EU variations regulation and guidelines

Last updated: 6 November 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

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: 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

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

EMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products

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…

Read MoreEMA and FDA launch pilot program for parallel scientific advice (PSA) for hybrid products and complex generic products