medicines-medical devices-regulatory affairs
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…
This guidance has been updated. It gives an overview of Orphan medicinal products to support development in rare disease, marketing exclusivity for the products, and how to apply. The authorisation of orphan medicinal products will change following implementation of the…
From 1 January 2025, there are changes to the legislation which affect Reference Medicinal Products (RMPs) used to support abridged applications for UK-wide marketing authorisations. Reference medicinal products (RMPs) are required for new generic medicines and other abridged marketing authorisation…
The processes for the following have been optimised: Normally, if the criteria for an FTP or a temp.auth. / temp.AI cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic, an Accelerated Application HeAring (AAA) usually takes…
This post is an attempt to present the details of a preliminary ruling by the CJEU on Case C-181/24 (Genmab A/S vs Budapest High Court) on the interpretation of Articles 3(b) and (d) of Supplementary Protection Certificate (SPC) Regulation (EC) No 469/2009, in…