medicines-medical devices-regulatory affairs
Last updated: 19 October 2024 To see updates, click on the ‘+’ sign below. The MHRA has published guidance on a new route for Marketing Authorisation Applications (MAAs) based upon rolling review, from 1 January 2021. What is the rolling…
The UK MHRA has developed a process to share operational information with health system partners across the UK. This applies to medicines applications submitted via National and International Recognition regulatory routes. For the purposes of operational information sharing, what is…
The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines. Module 1.2.1: Application form This application form must be used for the following Category 1 and COR…
Last updated: 4 February 2022 See updates at the bottom of the page. The UK MHRA has provided guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. The guidance has been provided as an electronic tool.…