New Innovative Licensing and Access Pathway (ILAP)
Last updated: 27 April 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…
Pharmavibes
medicines-medical devices-regulatory affairs
Read MoreNew Innovative Licensing and Access Pathway (ILAP)
CMDh and other EU updates – April 2026
Last updated: 27 April 2026 To view updates, click on the ‘+’ sign below. CMDh Multi-annual Workplan to 2028 The CMDh multi-annual workplan (MAWP) to 2028 outlines the priorities of the CMDh and reflects the need for a coordinated approach…
International regulatory news in brief
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.…
Medical Device Coordination Group (MDCG) updates – Apr – Jun 2026
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…
US FDA guidance for industry April – June 2026
Date Title of guidance and link to document Type and levelof guidance About the guidance 17 Apr 2026 Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers Level 1 Revised This guidance provides information for industry, researchers, physicians,…
New UK clinical trials regulations
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…
New MHRA-NICE aligned pathway and an improved Integrated Science Advice (ISA) service
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…
The EU electronic Product Information (ePI) initiative
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…
CMDh and other EU updates – March 2026
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…
The registration obligation for MD and IVD devices in Swissdamed
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.…
US FDA Guidance for Industry Jan-Mar 2026
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)…
The new Regulation (EU) 2021/2282 on Health Technology Assessment
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…