medicines-medical devices-regulatory affairs
Last updated: 20 June 2025 To view updates, click o the ‘+’ sign below. The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023. About the Innovative Devices Access Pathway (IDAP) The aim of IDAP is to enable and…
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents. Update 18 June 2025 Source: Swissmedic
Last updated: 11 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide basic information about patents, Supplementary Protections Certificates (SPCs) and Supplementary Protection Certificate (SPC) manufacturing waivers. The information provided is…
Last updated on 4 June 2026 See history of updates below. This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on…
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: 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: 10 April 2025 To view updates, click on the ‘+’ sign below: The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional…
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.…