medicines-medical devices-regulatory affairs
The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025. With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance…
Date Guidance No About the Guidance 18 Dec 2024 MDCG 2022-3 rev.1 Verification of manufactured class D IVDs by notified bodies All the changes to the document are reported on page 2. This document aims to provide guidance to notified…
For decades now, the Nordic pharmaceutical authorities have worked together to increase the availability of medicines in the Nordic countries with common Nordic packs for medicines. Source: Fimea
Last updated: 9 December 2024 SME Info day Here is a link to the EMA webinar SME Info Day held on on 18 October 2024. Time stamps for the various sessions in the webinar are provided below. 00:00:00 Session 1:…
Last updated: 24 July 2025 To see updates, click on the ‘+’ sign below: Understanding how to use AI based chatbots or search engines to search for information is important in order to improve your chances of getting a better…
The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations. This webinar details the upcoming implementation of new clinical trial regulations in the UK. How you might use…
Last updated: 9 April 2025 To view updates, click on the ‘+’ sign below: The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The…
Last updated: 6 November 2024 To see updates, click on the ‘+’ sign below. FDA is establishing the Split Real Time Application Review (STAR) pilot program under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This post is…
The UKs Dept. of Health and Social Care (DHSC) has published a policy paper entitled Design for Life roadmap. In tackling the above problem statements, the programme seeks to achieve 4 primary objectives. These are: Source: gov.uk
Last updated: 28 October 2024 Click on the + sign below to see the updates to this post. On 27 February 2023, the European Commission and the Government of the United Kingdom announced a political agreement in principal on a…
Last updated 25 October 2024 To view updates, click on the ‘+’ sign below The MHRA has published guidance on how to submit medicines pipeline information. It is requesting current or potential medicines Marketing Authorisation Holders (MAH) to provide information…
Last updated: 22 October 2024 Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle This reflection paper provides considerations on the use of AI/ML in the lifecycle of medicinal products, including medicinal products development, authorisation, and post-authorisation. Given…