medicines-medical devices-regulatory affairs
Date Title of guidance and link to document Type and levelof guidance About the guidance 5 Feb 2025 Institutional Review Boards Frequently Asked Questions Final This a compilation of answers to questions asked of FDA regarding the protection of human…
Last updated: 5 February 2025 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 updated: 3 February 2025 To view updates, click on the ‘+’ sign below. Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh You can view the decisions here. Source: HMA Updated eAF…
31 January 2025 The Canada-Switzerland MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP has been in force since 2000. The text of the MRA has not yet been revised as this interpretation was possible on the…
The legal requirements for the maintenance of medical devices are regulated in: Swiss Good Practice for the Maintenance of Medical Devices (GPI) The “Swiss Good Practice for the Maintenance of Medical Devices” (GPI) is a guideline that explains the requirements…
This is an attempt to present the facts leading to the outcome of the appeal request concerning Supplementary Protection Certificates (SPCs) in the case of Halozyme Inc. vs the UK Intellectual Property Office (IPO). The parties concerned Halozyme Inc. vs…
Medicines regulators in the Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) have recently launched the Nordic Packaging pilot which will run until 2030. The pilot will investigate the provision of packs containing English-only labelling and the package leaflet printed in English for…
Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format Health Canada has updated the validation rules for regulatory transactions submitted in the eCTD format, to reflect recent and upcoming changes in its processes. These rules are built…
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 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…
Last updated: 3 January 2025 To view updates, click on the ‘+’ below: This post is an attempt to to provide information on recent progress concerning two cases, one from the Finnish Market Court C-119/22 (Teva v MSD) and the…
Date Title of guidance and link to document Type and levelof guidance About the guidance 31 Dec 2024 Advanced Manufacturing Technologies Designation Program Final, Level 1 This guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced…