medicines-medical devices-regulatory affairs
Date Guidance No About the Guidance 6 Dec 2024 MDCG 2024-16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices 2 Dec 2024 MDCG 2024-15 Guidance on the publication…
Date Title of guidance and link to document Type and levelof guidance About the guidance 6 Dec 2024 Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance…
Last updated: 6 December 2024 To see updates click on the ‘+’ sign below. This post is an attempt to provide basic information on some Artificial Intelligence (AI) based chatbots or search engines. Chatbot/search engine Company Access via website? Access…
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: 3 December 2024 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: 26 November 2024 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 guideline. Timeline of events leading to the publishing of…
Last update: 26 November 2024 To view the updates, please click on the ‘+’ sign below. Report from the CMDh meeting held on 12-14 November 2024 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of…
Last updated: 23 November 2024 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: 22 November 2024 SME Info day Here is a link to the EMA webinar SME Info Day held on on 18 October 2024. Time stamps for the various sessions in the webinar are provided below. 00:00:00 Session 1:…
Last updated: 21 November 2024 To see updates, click on the ‘+’ sign below. Post Brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland…