medicines-medical devices-regulatory affairs
Last updated: 11 March 2025 To view updates, click on the ‘+’ sign below. On 23 September, the updated 2024 ABPI Code of Practice was launched. It seeks to raise the high standards expected of pharmaceutical companies even further while…
Last updated: 5 March 2025 To view updates, click on the ‘+’ sign below. Multi-stakeholder workshop on Pharmacogenomics In September 2024 the European Medicines Agencies Network (EMA and HMA) and the European Commission co-hosted a multi-stakeholder workshop on pharmacogenomics. The…
Between 6 February 2025 and 28 February 2025, the following guidances issued by the MHRA were updated: Guidance updated – Format and content of applications for agreement or modification of a Paediatric Investigation Plan This guidance provides detailed information on: …
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…
Last updated: 12 January 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…
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…