medicines-medical devices-regulatory affairs
The UK MHRA and Health Canada have collaborated to publish guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs). The guidance will improve the…
The UK MHRA has published its new Delivery Plan 2021-2023. The plan has one overarching goal which is to deliver for patients and the public. The new plan is designed to bring together and prioritise the MHRAs existing efforts in…
The UK MHRA has updated its requirements and guidance for Phase I accreditation scheme for clinical trials. It has also provided a new phase I accreditation compliance checklist and variation form. What is the Phase I accreditation scheme? It is…
Following a consultation in 2020, the UK MHRA has published detailed guidance on the licensing of biosimilar products. Who is the guidance for? The purpose of the guidance is to provide developers of similar biological medicinal products (aka biosimilars) with…
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.…
The MHRA has updated its guidance on applying for a variation to your marketing authorisation. The original guidance was published in December 2014. Following the end of the transition period on 31 December 2020, the guidance has been updated with…
The UK MHRA has updated is guidance on variations to Marketing Authorisations (MAs) from 1 January 2021. The original guidance was published on 27 October 2020. In the latest update, further information is provided on variations for products that were…