medicines-medical devices-regulatory affairs
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.…
Last updated: 19 October 2023 See updates at the end of the post. Clinical Trials Regulation (EU) No 536/2014 Questions and Answers The Q & A document has been updated to Version 6.6 of September 2023. You can view it…
Last updated: 28 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 24-26 January 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Last updated: 27 February 2023 See updates at the end of the post. EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 Revision 1 of the above document dated 15 Feb…
Last updated: 6 February 2023 See history of updates below This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign…
The EMA has updated its post-authorisation procedural advice for users of the centralised procedure. The latest version of the Q & A advice document, Rev. 99 is dated 20 June 2022. Here, you can view the track changed and clean…
The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained. About the SNSA pilot The EU Innovation Network started a…