medicines-medical devices-regulatory affairs
Last updated: 17 July 2026 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 on 16 July 2026 To view updates, click on the ‘+’ sign below. Human Medicines Division Pre-notification check for Type IB Variations Here you can view the updated (July 2026) document with the above title. European Medicines Agency…
Last updated: 17 July 2026 To view updates, click on the ‘+’ below. The Government announced in its Regulatory Action Plan on the 17 March 2025 that the AI Airlock will run another phase during the 2025-2026 financial year. Applicants…
Last updated: 17 July 2026 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…
Health Canada is encouraging the introduction of new drugs (therapies, treatments, and medicines) to Canada by modernising its regulatory review process. This is being done in a number of ways as follows: Pharmaceutical and Life Sciences Task Force Ministerial Reliance…
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: 15 July 2026 Below is an attempt to provide information on the new clinical trials regulations. The information is by no means complete or exhaustive. Please use this post as a starting point and take the time to…
You can listen to available guidance podcasts at this link. Date Title of guidance and link to document Type and levelof guidance About the guidance 15 Jul 2026 Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors…
Last updated: 14 July 2025 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…
Last updated: 2 July 2026 For updates, click on the ‘+’ sign below. This post aims to provide basic information on the FAST-EU initiative. The information is by no means exhaustive. What is the FAST-Initiative? FAST-EU (Facilitating and Accelerating Strategic…
Last updated: 1 July 2026 To view updates, click on the + sign below: IRIS guide for applicants updated The above guide on how to create, submit and manage IRIS applications, centralised product contacts for industry and individual applicants was…
Last updated: 29 June 2026 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…