medicines-medical devices-regulatory affairs
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.…
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: 8 October 2025 To view updates, click on the ‘+’ sign below Q&A Clinic on web based electronic Application Form eAF functionalities This is a video of a Q&A Clinic webinar hosted by the EMA on 30 September…
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…
Last updated: 3 October 2025 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots or search engines. Chatbot/search engine Company Access via website? Access…
Last updated: 2 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…
Last updated: 30 September 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: 27 September 2025 To view updates, click on the ‘+’ sign below. Paediatric-use marketing authorisations The Application process section on this page of the EMA website has been updated. Source: EMA IRIS guide to registration and Research Product Identifiers…
Last updated: 27 September 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…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Sep 2025 E20 Adaptive Designs for Clinical Trials Draft, Level 1 This document provides guidance on confirmatory clinical trials with an adaptive design intended…
Last updated: 24 September 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to walk through European Union (EU) medicines legislation starting from the 1960s. It has been difficult to strike a balance between…