Category MHRA (UK)

New MHRA guidance on the assessment of established medicines in order to help applicants and shorten time frames

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…

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MHRA guidance on operational information sharing for relevant regulatory applications

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…

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