medicines-medical devices-regulatory affairs
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…
The EMA has launched a new pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). This pilot programme is part of EMA’s regulatory support for the expert panels on…
Last updated: 2 August 2024 To see updates, click on the ‘+’ sign below. SPOR status update This EMA webinar was held on 10 July 2024. It covers the following topics: Source: EMA Template for notified body confirmation letter of…
This post concerns the introduction of temporary new arrangements by the TGA, for GMP inspections of: When were the temporary new arrangements for GMP inspections introduced and what are they called? The temporary new arrangements for GMP inspections were introduced…
Last updated: 13 July 2024 To see updates to this post, click on the ‘+’ sign below. This post summarises the proposal and main events so far concerning the extension of the IVDR transition periods. Timeline of events Date Event…
Last updated: 14 July 2024 Click on the + sign below to see the updates to this post. ICH eCTD v4.0 package updated The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within…