medicines-medical devices-regulatory affairs
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 20 Oct 2026 Regulatory Considerations for Prescription Drug Use-Related Software Final, Level 1 This guidance…
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.…
About the pilot program The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches (namely leveraging QRIs and a new rolling review process) for accelerating first-in-human (FIH) clinical trials in the United…
Last updated: 10 October 2026 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…
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure Here, you can view the track changed (13 July 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions…
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…
AI Airlock Background The AI Airlock was established to proactively investigate the regulatory challenges of AI as a Medical Device. Working with key partners during the pilot phases, the programme is working towards key project outputs including an improved regulatory…
Last updated: 30 September 2026 To see updates, click on the ‘+’ sign below. The MHRA has 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…
Last updated: 30 September 2026 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: 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: 17 September 2026 To view updates, click on the ‘+’ sign below The MHRA offers a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after 3rd April…