medicines-medical devices-regulatory affairs
Last updated: 14 March 2026 To view updates, click on the ‘+’ sign below: EU eCTD v4.0 validation criteria v1.1 published Following the consultation period, the final version of the EU eCTD v4.0 Validation Criteria v1.1 is now available. For any concerns,…
Last updated: 13 March 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…
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: 10 March 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, search engines and other AI based software. Chatbot/search engine Company…
Last updated: 9 March 2026 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…
Last updated: 9 March 2026 To view updates, please click on the ‘+’ sign below: Date Update(s) to the position paper 9 Mar 2026 The Annexes have been revised to reflect the updated recommendation paper of the European Commission’s Directorate-General…
Date Title of guidance and link to document Type and levelof guidance About the guidance 6 Mar 2026 Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Draft, Level 1 This guidance is intended for…
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…
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…
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…