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: 16 May 2025 To view updates, click on the ‘+’ sign below. Updated PLM Portal eAF Release notes now available An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in…
Last updated: 9 May 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present in a tabular format, information on the the currently available UK marketing authorisation routes for medicines. The information is…
Last updated: 7 May 2025 To view updates, click on the ‘+’ sign below. For a basic introduction to IDMP, watch this clip from the Uppsala Monitoring Centre, Sweden. Some more information is available in this blog post. The EU…
Last updated: 1 May 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: 1 May 2025 To see updates, click on the ‘+’ sign below. How were these reforms developed? The reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals…
Last updated: 28 April 2025 To view updates, click on the ‘+’ sign below eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025 A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website.…
Last updated: 28 April 2025 To view updates, click on the ‘+’ sign below. The table below is an attempt to present some court cases involving Supplementary Protection Certificates. You can read more about Supplementary Protection Certificates (SPCs) and Supplementary…
Last updated: 25 April 2025 To view updates, click on the ‘+’ sign below: This post is an attempt to provide basic information on electronic Product Information (ePI) in the EU What is the definition of Product Information (PI) and…
Last updated: 4 April 2025 The UK MHRA has published guidance on the International Recognition Procedure which became operational on 1 January 2024. This post is an attempt to present the information in a Q&A format. The information is by…