medicines-medical devices-regulatory affairs
Date Guidance No About the guidance 3 Nov 2026 MDCG 2026-6 Clinical evidence for orphan in vitro diagnosticmedical devices This document provides guidance to manufacturers, notified bodies, expert panels, health institutions,and regulators on the clinical evidence requirements for orphan IVDs…
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 30 Oct 2026 E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and…
Last updated: 29 October 2026 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
Last updated: 28 October 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…
Below is an attempt to provide information with the intention of facilitating a better understanding of the progress with the update to the EU pharmaceutical legislation. The proposed revision of the pharmaceutical legislation will consist of two legislative proposals: The…
Last updated: 27 October 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: 22 October 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…
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…
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…