medicines-medical devices-regulatory affairs
Last updated: 22 September 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. The commission delegated regulation Timeline of events leading…
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: 20 August 2025 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
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: 5 August 2025 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…
Last updated: 14 August 2025 To view updates, click on the ‘+’ sign below. PLM Portal FHIR XML version upgrade The PLM portal FHIR XML version was updated to 2.2.3. The new version introduces the following changes: • There’s a new…