medicines-medical devices-regulatory affairs
This post covers international regulatory news in brief. It is updated on an ad hoc basis. For ease of navigation, a tab has been added for each region/topic (below). Each tab includes the date for most recent update under that particular tab.…
Last updated: 11 October 2024 To see updates, click on the ‘+’ sign below The Windsor framework was covered in a previous post. On 9 June 2023, the MHRA published a medicines announcement associated with the framework. It sets out…
Last updated: 9 October 2024 EU eCTD v4.0 draft Implementation package now available An updated draft version of the EU eCTD v4.0 implementation package is now available here. The package contains the following: An upcoming updated package (containing the genericode files…
Date Guidance No About the Guidance 8 Oct 2024 MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices (October 2024) The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on…
Last updated: 8 October 2024 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: 3 October 2024 Click on the + sign below to see the updates to this post. On 27 February 2023, the European Commission and the Government of the United Kingdom announced a political agreement in principal on a…
Last updated: 2 October 2024 This post is an attempt to provide basic information on Health Technology, its assessment and the new Regulation (EU) 2021 Click on the ‘+’ sign next to each heading to access the information under each…
Date Title of guidance and link to document Type and levelof guidance About the guidance 1 Oct 2024 Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers Final This document provides guidance to sponsors, clinical investigators,…
Last updated: 1 October 2024 To view updates, click on the ‘+’ sign below. The UK MHRA offers a pre-submission service before applying for medicines Marketing Authorisations. For International recognition For New Active Substances and/or complex applications For ACCESS and…
Last updated: 30 September 2024 To view updates, click on the ‘+’ sign below. On 23 September, the updated 2024 ABPI Code of Practice was launched launched. It seeks to raise the high standards expected of pharmaceutical companies even further…