medicines-medical devices-regulatory affairs
Last updated: 6 October 2026 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: 28 September 2026 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: 25 September 2026 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: 13 September 2026 To view updates, click on the ‘+’ sign below. What are combined studies? Combined studies can be understood as studies that involve: What is COMBINE initiative? COMBINE is one of the initiatives highlighted in the Draghi…
Last updated: 30 July 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. Legal Framework The table below provides inforation on the…
Date Guidance No About the guidance June 2026 MDCG 2021-5 rev.1 – Appendix Guidance on standardisation for medical devicesAppendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1 June 2026 MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in…
Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the…
The European Commission has published new and updated guidance documents in Volume 10 of “The Rules Governing Medicinal Products in the European Union”, which applies to clinical trials under the Clinical Trials Regulation (EU) No 536 These updates, published on…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) published Version 1.0 of the recommendation paper on decentralised elements in clinical trials on 14 December 2022. It was updated in October 2025 (Version 2) . The…
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…