medicines-medical devices-regulatory affairs
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: 9 June 2025 See updates below. This post is an attempt to provide basic information about the Access Consortium, a collaborative initiative of regulatory agencies. Click on the ‘+’ sign next to each heading to access the information…
Last updated: 16 June 2025 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…
Last updated: 12 June 2025 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…
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…