medicines-medical devices-regulatory affairs
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…
Last updated: 1 February 2025 To see updates, click on the ‘+’ sign below The Windsor framework was covered in a previous post. The guidances in the table below are covered in this post. Only a snapshot of each guidance…
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…
On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE),…
Last updated: 30 January 2025 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…
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…
Last updated: 17 2025 To see updates, click on the ‘+’ sign below. New clinical trials draft legislation (Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024) was laid in Parliament on 12 December 2024. it will address the research…
Last updated: 16 January 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to outline the timeline of proposed changes to the UK regulatory framework for medical devices, including the transitional arrangements. The regulations…
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…