medicines-medical devices-regulatory affairs
Last updated: 22 April 2026 To view updates, click on the ‘+’ sign below. Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 You can view Version 5 of the updated manual here. Frequently asked…
Date Guidance No About the guidance Apr 2026 MDCG 2026-3 2026 EMDN Version History Apr 2026 MDCG 2026-2 2025-2026 Annual Revision Change Log Apr 2026 MDCG 2026-1 EMDN UPDATE SUBMISSIONS FROM 2025 PUBLIC CONSULTATION AND THE MDCG NOMENCLATURE WORKING GROUP…
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 17 Apr 2026 Establishing Impurity Specifications for Antibiotics Draft, Level 1 This guidance provides recommendations to industry for establishing specifications for impurities in antibiotics manufactured…
Last updated: 17 April 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…
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.…
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…