medicines-medical devices-regulatory affairs
Last updated: 16 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory…
Last updated: 28 May 2026 To view updates, click on the ‘+’ sign. Q&A on Periodic Safety Update Report (PSUR) Single-Assessment (PSUSA): Guidance document for assessors Revision 1 (17 Apr 2026) of the documents with the above title has been…
This post is an attempt to provide salient information on Case C-456/24 which concerns Halozyme Inc. vs the Supreme Administrative Court, Czech Republic. Specifically, it concerns the events leading up to the CJEU getting involved in the case as well…
Last updated: 11 May 2026 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
Last updated: 6 May 2026 To view updates, click on the ‘+’ sign below. The EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). EMA launched this pilot on 28 April 2026.…
Last updated: 5 May 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: 30 April 2026 To view updates, click on the ‘+’ sign below. Clinical Trial Information System (CTIS) – Sponsor Frequently Asked Questions (FAQ) The CTIS Sponsor Frequently Asked Questions (FAQ) is based on questions frequently raised by sponsors during CTIS events such as walk-in clinics, bitesize…
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: 5 May 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)…
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…