medicines-medical devices-regulatory affairs
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…
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.…