medicines-medical devices-regulatory affairs
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…
Last updated: 14 July 2025 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: 26 October 2025 See history of updates below. The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project will have a wide ranging and positive impact on industry stakeholders…
Last updated on 9 July 2025 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 on 8 July 2025 See history of updates below. This post is an attempt to provide an information resource for the Medical Devices Regulation (EU) 2017/745 (MDR). The information provided is by no means exhaustive or complete. Although…