medicines-medical devices-regulatory affairs
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…
Intensified exchange Swissmedic – Company in the labelling phase In order to avoid text review letters whenever possible, this direct exchange by means of an informal letter via the eGov portal should be used more frequently. Therefore, from January 1,…
The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025. With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance…
Date Guidance No About the Guidance 18 Dec 2024 MDCG 2022-3 rev.1 Verification of manufactured class D IVDs by notified bodies All the changes to the document are reported on page 2. This document aims to provide guidance to notified…
For decades now, the Nordic pharmaceutical authorities have worked together to increase the availability of medicines in the Nordic countries with common Nordic packs for medicines. Source: Fimea
Last updated: 9 December 2024 SME Info day Here is a link to the EMA webinar SME Info Day held on on 18 October 2024. Time stamps for the various sessions in the webinar are provided below. 00:00:00 Session 1:…