medicines-medical devices-regulatory affairs
Last updated: 29 August 2024 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 (albeit not in its entirety) in a Q&A…
Last updated: 14 June 2024 To see updates, click on the ‘+’ sign below. Post Brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland…
New guidance has been published on the MHRA website concerning process changes for the assessment of established medicines that come into effect on 1 March 2024. This post is an attempt to present the guidance information in a manner that…
The table below details changes to five guidance documents (listed in column 1 below) for the authorisation of human medicinal products. Updated guidance document Document (plus form where applicable) What the document concerns Changes to the document Sections of the…
The UK MHRA has announced today that new regulatory recognition routes for medicines will be established using approvals from the following countries: This means that patients will have access to safe and effective medicines that have been approved by trusted…
Health Canada has updated guidances concerning pre and post-licensing submissions and performance standards for PDCs for prescription pharmaceutical drugs and those administered or obtained through a health professional. Notice: Revision to the Guidance Document Management of Drug Submissions and Applications…
Is the FDA allowing medicines authorised via the accelerated approval process to remain so in spite of unproven clinical effectiveness? According to an investigation by the British Medical Journal (BMJ), 112 of the 253 drugs authorised by the FDA via…