medicines-medical devices-regulatory affairs
Medical Devices (MD) registration When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period? The registration of devices, systems, and procedure packs according to Art.…
Date Title of guidance and link to document Type and levelof guidance About the guidance 27 Mar 2026 Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Final This guidance provides recommendations on how voluntary “patient preferenceinformation” (PPI)…
What action(s) is the MHRA taking in order to phase out animal testing? The MHRA has taken decisive action to phase out animal testing by helping developers to make greater use of New Approach Methodologies (NAMs). By offering early review…
Last updated: 9 March 2026 To view updates, please click on the ‘+’ sign below: Date Update(s) to the position paper 9 Mar 2026 The Annexes have been revised to reflect the updated recommendation paper of the European Commission’s Directorate-General…
Last updated: 5 March 2026 To view updates, click on the ‘+’ sign below. Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert…
Last updated 27 February 2026 To view updates, click on the ‘+’ sign below. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers (Final document) This document: Source: IMDRF List of…
On 4 February 2026, the The Prescription Medicines Code of Practice Authority (PMCPA) published revised social media guidance as a new dedicated section of its website. This guidance: The guidance: The guidance is split into the sections show below, for…
On 19 January 2026, The Prescription Medicines Code of Practice Authority (PMCPA) guidance on package deals was published. There are many different types of package deals and therefore it is difficult for the PMCPAto give universal guidance in this area.…
About the reliance pilot programme EMA and WHO are supporting a pilot programme that enables pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities. Why is the reliance pilot programme deemed necessary? Regulatory authorities use reliance extensively when…
Last updated: 3 February 2026 To view updates, click on the ‘+’ sign below. The worksharing procedure for the assessment of Active Substance Master File (ASMF) The document with the above title has been updated. Here, you can view the…
Last updated: 30 January 2026 See updates below. This post is an attempt to provide basic information about the Access Consortium, a collaborative initiative of regulatory agencies. Click on the ‘+’ sign next to each heading to access the information…
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…