medicines-medical devices-regulatory affairs
Last updated: 27 September 2025 To view updates, click on the ‘+’ sign below. Paediatric-use marketing authorisations The Application process section on this page of the EMA website has been updated. Source: EMA IRIS guide to registration and Research Product Identifiers…
Date Title of guidance and link to document Type and levelof guidance About the guidance 26 Sep 2025 E20 Adaptive Designs for Clinical Trials Draft, Level 1 This document provides guidance on confirmatory clinical trials with an adaptive design intended…
Last updated: 11 December 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to walk through European Union (EU) medicines legislation starting from the 1960s. It has been difficult to strike a balance between…
On 3 September 2025, FDA’s CDER and CBER proposed a new process under Rare Disease Evidence Principles (RDEP) to facilitate the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need and with…
This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…
In this post, information is provided on the following updated guidance documents: Changes to the guidance document Time limits for authorisation applications Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active…
Last updated: 27 August 2025 To view updates, click on the ‘+’ sign below. eCTD v4.0- Controlled Vocabularies v2 (genericode format) now available eCTD v4.0 technical pilot phase 2 update Source: eSubmission PLM Portal eAF – FHIR 2.2.5 – planned…
Date Guidance No About the guidance 26 Aug 2025 MDCG 2024-14 – rev.1 Guidance on the implementation of the Master UDI-DI solution for contact lenses This document aims to provide guidance in the implementation of Master UDI-DI rules for contact…
Last updated: 14 August 2025 To view updates, click on the ‘+’ sign below. On 17 November 2023, the UK MHRA published updated guidance on change of ownership of Medicines Marketing authorisation, to reflect a new process and application form.…
Last updated: 8 August 2025 To view updates, click on the ‘+’ sign below: The information for this post has been obtained from the report (of 1 April 2024) with the title above, published on 6 August 2025. Whilst the…
Last updated: 9 February 2026 To see updates, click on the ‘+’ sign below The Windsor framework was covered in a previous post. The guidances in the table below are covered in this post. Only a snapshot of each guidance…
Last updated: 15 September 2025 To view updates, click on the ‘+’ sign below. What is Decentralised Manufacturing? Point of Care (POC) and Modular Manufacture (MM) are collectively described as Decentralised Manufacture (DM). Which product types are included as POC…