medicines-medical devices-regulatory affairs
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…
Last updated: 6 November 2025 To view updates, click on the ‘+’ sign below. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure The document with the above title has been updated and republished (28 October 2025).…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Oct 2025 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Further reading:FDA relaxes biosimilars…
Last updated: 6 November 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: 30 October 2025 To view updates, please click on the ‘+’ sign below: Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products to Version 3.3 of 27 October 2025. Unfortunately, no information has…
Last updated: 27 October 2025 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: 20 October 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: 18 October 2025 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway. This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce…
Last updated: 11 October 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
Last updated: 4 October 2025 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…