medicines-medical devices-regulatory affairs
Last updated: 14 April 2026 To view updates, click on the ‘+’ sign below. Mandatory Use of PLM Web-Based eAF for CAPs from 1 September 2026 The strongly recommended use of the PLM web-based electronic Application Form (eAF) for Centrally…
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 10 Apr 2026 Bioanalytical Method Validation for Biomarkers Final, Level 2 This guidance helps sponsors of INDs and applicants of NDAs, BLAs, and NDA and…
Last updated: 14 April 2026 To view updates, click on the ‘+’ sign below: On 1 April 2026, the MHRA and NICE launched an aligned pathway together with an improved Integrated Scientific Advice service to accelerate patient access to medicines…
Last updated: 1 April 2026 To view updates, click on the ‘+’ sign below: This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU. What is the definition of Product Information (PI) and…
Last updated: 1 April 2026 To view updates, click on the ‘+’ sign below: Updated EU Commission Q&A guidance on EU Clinical Trials Regulation (CTR) and revised versions of several Clinical Trials Coordination Group (CTCG) templates An updated version (v7.2…
Medical Devices (MD) registration When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period? The registration of devices, systems, and procedure packs according to Art.…
Last updated: 28 March 2026 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…
Date Title of guidance and link to document Type and levelof guidance About the guidance 27 Mar 2026 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Final This guidance provides recommendations on how voluntary “patient preferenceinformation” (PPI)…
Last updated: 26 March 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: 24 March 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 a in an easy…
What action(s) is the MHRA taking in order to phase out animal testing? The MHRA has taken decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs). By offering early review…