medicines-medical devices-regulatory affairs
Last updated: 25 April 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: 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…
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: 17 April 2025 To view updates, click on the ‘+’ sign below PSUSA procedures: new requirement for Word version of the PSURs and RSI responses When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation…
Last updated: 10 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: 16 April 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: 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…
Last updated: 4 April 2025 To see updates, click on the ‘+’ sign below. This post is an attempt to present the guidance on MAAs based upon a rolling review, in a Q&A format. Always read the guidance on this…
Last updated: 4 April 2025 To see updates, click on ‘+’ sign below The UK MHRA has published guidance on the Project Orbis initiative. Please read this post in conjunction with the MHRA guidance. About the Project Orbis initiative Which…
The MHRA offers a national assessment procedure for UK-wide marketing authorisation (MA) applications. This new guidance for applicants is effective for applications received after 3rd April 2025, the publication date. Always read the guidance on this procedure published on the…