medicines-medical devices-regulatory affairs
Last updated: 28 March 2025 To view updates click on the ‘+’ sign below: Artificial Intelligence (AI) is slowly but inexorably creeping into our lives in everything that we do. Not a day goes by without new stories in the…
This blog post provides basic information on decentralised clinical trials and links to guidance/resources available in various countries/region(s). What is decentralisation? Clinical trials on Investigational Medicinal Products are increasingly using procedures conducted outside the traditional ‘clinical trial site’, a concept…
Lost updated: 14 November 2023 See updates at the end of this post. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list has been updated and you can download the latest version…
Last updated: 14 November 2023 See all updates at the end of this post. Swissmedic has published guidance on the requirement for Swiss authorised representative (CH-REP) for medical devices. Definition of a Swiss authorised representative Natural or legal person in…
Since the end of November 2022 when Open.ai introduced ChatGPT to the world, there has been an explosion of chatbots which include the following: Some of these are chatbots e.g. ChatGPT and others are search engines e.g. Perplexity.ai or Microsoft…
Last Updated: 1 November 2023 See updates at the end of the post. This post is an attempt to inform the reader about the FDA’s Knowledge-Aided Assessment and Structured Application (KASA) system. Please note that at the time of last…
This post is an attempt to provide basic information on the International Council for Harmonisation (ICH) and its functions. Click on the ‘+’ sign next to each heading to access the information under each heading. Source: ICH Please share any…
Last updated: 19 October 2023 See updates at the end of the post. Clinical Trials Regulation (EU) No 536/2014 Questions and Answers The Q & A document has been updated to Version 6.6 of September 2023. You can view it…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Sep 2023 Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”OCTOBER 2023 Source: FDA…
Last updated on 26 September 2023 See updates at the end of the post. Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation The European Commission recently published guidance on the transition…
Last updated: 25 July 2024 See updates at the end of the post. This post is an attempt to facilitate an understanding of some of the complexities associated with the affixing of proprietary trademarks to repackaged generic medicinal products, for…
The table below details the Timeline of proposed changes to the regulatory framework for clinical trials in the UK. Date(s) Event Notes 17 Jan -14 Mar 2022 MHRA public consultation on proposals for legislative changes for clinical trials. This consultation…