medicines-medical devices-regulatory affairs
The MHRA has today published guidance on a Phase 1, 14-day pilot programme for clinical trials. Below is an attempt to present the information in a Q&A format. To read the complete guidance, visit this MHRA page. Which trials does…
Date Event Further information 16 Dec 2025 The EU commission published a Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices The details of the Commission Proposal are discussed in this post1. 1 July 2026…
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.…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 12 Aug 2026 Container Closure Systems for Human Drugs and Biological Products Draft, Level 1…
Last updated: 13 August 2026 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: 13 August 2026 To view updates, click on the ‘+’ sign below. Reminder: mandatory use of PLM web-based eAF for CAPs – 1 September 2026 As announced in April 2026, the European Medicines Agency (EMA) is introducing the…
Last updated: 7 August 2026 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots, search engines and other AI based software. Chatbot/search engine Company…
Last updated: 5 August 2026 To view updates, click on the ‘+’ sign below: On 30 January 2025, the new ILAP was launched by the following: Below is an attempt to lay out the guidance in an easy to understand…
Last updated: 3 August 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: 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…
Last updated on 30 July 2026 To view updates, click on the ‘+’ sign below. Templates variation assessment report Here, you can view the track changed (Mar 2026) and clean (Jul 2026) versions of the document Type II variation Preliminary-Final…
Last updated: 27 July 2026 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…