medicines-medical devices-regulatory affairs
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…
Last updated: 1 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA offers a pre-submission service before applying for medicines Marketing Authorisations. For International recognition For New Active Substances and/or complex applications For ACCESS and…
Date Title of guidance and link to document Type and levelof guidance About the guidance 25 Sep 2024 Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Final This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting…
Date Guidance No About the Guidance 25 Sep 2024 MDCG 2021-4 rev.1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746 – September 2024 This essentially a Q&A document.The revisions are…
Last updated: 23 September 2024 To view updates, click on the ‘+’ sign below. Management of rapid alerts arising from quality defects risk assessment The document with the above title was adopted on 15 June 2024 and came into forse…
Last updated: 23 September 2024 To see updates, click on the ‘+’ sign below. On 30 April 2024, the MHRA set out its strategic approach to AI in response to a white paper published in 2023 by Government. On 9 May 2024,…
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Last updated: 6 August 2024 This post is an attempt to provide basic information about Swissdamed and progress with its availability. To see the updates, click on ‘+’ sign below. About Swissdamed Swissdamed is Swissmedic’s new database for registering economic…