medicines-medical devices-regulatory affairs
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 1 Jul 2026 Submitting Next-Generation Sequencing Data to the Division of Antiviral Products Final, Level…
Human MAA eAF v1.28.0.0 – timeline for implementation Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application are available on the eAF website, together with the associated release notes. You can better view the…
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: 29 June 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…
Last updated on 29 June 2026 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…
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 25 Jun 2026 Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level…
Last updated: 23 June 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…
Date Guidance No About the guidance June 2026 MDCG 2021-5 rev.1 – Appendix Guidance on standardisation for medical devicesAppendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1 June 2026 MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in…
Last updated: 16 June 2026 To view updates, click on the ‘+’ sign below. This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory…
Last updated: 9 June 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: 8 June 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…