medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 8 May 2026 Postapproval Pregnancy Safety Studies Final, Level 1 The purpose of this guidance is to provide sponsors and investigators with recommendations on how…
Last updated: 8 May 2026 To view updates, click on the ‘+’ sign. Update – Notified bodies survey on certifications and applications (8 May 2026) You can view the slide deck on the latest update here. COMMISSION IMPLEMENTING REGULATION (EU)…
Last updated: 4 March 2026 To view updates, click on the ‘+’ sign below. This post provides information on the changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. Legal Framework What are some of the changes introduced…
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.…
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: 5 May 2026 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…
Last updated: 5 May 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: 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: 28 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: 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…
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…
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…