medicines-medical devices-regulatory affairs
Reminder – New variation classification in eAF The updated Variation Regulation Classification Guideline has been made available in both the interactive pdf eAF v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version. Users are reminded to verify…
Last updated: 5 March 2026 To view updates, click on the ‘+’ sign below. Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert…
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: 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…
Date Title of guidance and link to document Type and levelof guidance About the guidance 3 Mar 2026 M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines Final…
Last updated 27 February 2026 To view updates, click on the ‘+’ sign below. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers (Final document) This document: Source: IMDRF List of…
Last updated: 26 February 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…
On 4 February 2026, the The Prescription Medicines Code of Practice Authority (PMCPA) published revised social media guidance as a new dedicated section of its website. This guidance: The guidance: The guidance is split into the sections show below, for…
Last updated: 22 February 2026 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots or search engines. Chatbot/search engine Company Access via website? Access…
Last updated: 16 February 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: 13 February 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…
On 19 January 2026, The Prescription Medicines Code of Practice Authority (PMCPA) guidance on package deals was published. There are many different types of package deals and therefore it is difficult for the PMCPAto give universal guidance in this area.…