medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 13 Jan 2025 The Office of the Chief Medical Officer (OCMO) has shared the following lists of guidance documents for public review and input:• Guidance documents it intends…
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Last updated: 11 January 2025 To view updates, click on the ‘+’ sign below. Important note to Product Lifecycle Management Portal PLM Portal users Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product…
Date Guidance No About the guidance 10 Jan 2025 MDCG 2024-7 rev.1 MDCG 2024-7 Annex Preliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents) 7 Jan 2025 MDCG 2023-3 rev.2 Questions and…
Last updated: 10 January 2025 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Last updated: 10 January 2025 To view updates, click on the ‘+’ sign below. This post is an attempt to to provide information on Case C-237/22 concerning Mylan IRE Healthcare v European Commission, including clarification of the concepts of “Significant…
Last updated: 9 January 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: 9 January 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: 7 January 2024 To view updates, click on the ‘+’ below: Minutes and presentations from the 20 November 2024 meeting with Interested Parties You can view the minutes of the meeting here and most of the presentations from…
Last update: 7 January 2025 To view the updates, please click on the ‘+’ sign below. Report and minutes from the CMDh meeting held on 12-14 November 2024 The reports from the CMDh meetings (also called press releases) reflect highlights/important…