medicines-medical devices-regulatory affairs
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…
Last updated: 2 April 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: 16 April 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 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: 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…
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…
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: 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.…