medicines-medical devices-regulatory affairs
Last updated: 27 May 2025 To see updates, click on the ‘+’ sign below The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific…
Last updated: 22 May 2025 To view updates, click on the ‘+’ sign below The MHRA offers a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after 3rd April…
Last updated: 9 May 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is…
Last updated: 28 April 2025 To view updates, click on the ‘+’ sign below eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025 A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website.…
Last updated: 25 April 2025 To view updates, click on the ‘+’ sign below: This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU What is the definition of Product Information (PI) and…
Last updated: 13 May 2025 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 4 April 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on MAAs based upon a rolling review, in a Q&A format. Always read the guidance on this…
Last updated: 3 April 2025 To view updates, click the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this procedure…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the scheme for Conditional Marketing Authorisations in a Q&A format. Always read the information on this…
Last updated: 3 April 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on the Unfettered Access Procedure (UAP) for marketing authorisations approved in Northern Ireland in a Q&A format.…
To ensure that questions from companies relating to the development and approval of medicinal products can be clarified efficiently and purposefully in dialogue with Swissmedic, it has optimised the possibilities for company meetings. Source: Swissmedic
Last updated: 31 March 2025 To view updates, click on the ‘+’ sign below: Update – MedEthicsEU report – Survey on National Part II Clinical Trial Application (CTA) requirements (March 2025) Overview part II requirements in a Clinical Trial application…