medicines-medical devices-regulatory affairs
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…
This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guideline. Timeline of events leading to the publishing of the commission delegated regulation Date Event Call for evidenceFeedback period29 August 2023 – 26…
Last updated: 30 May 2024 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: 26 April 2024 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: 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…
Last updated: 31 January 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 12-14 December 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…
Last updated: 28 November 2023 See updates at the end of the post. In September 2021, the European Medicines Agency (EMA) provided final feedback to the European Commission (EC) on its request to evaluate the impact of the removal of…
Last updated: 28 November 2023 See updates at the end of the post. The European Medicines Agency (EMA) has published technical and procedural guidance on the replacement/removal of titanium dioxide (TiO2) in medicines. You can view it on this page.…