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Thursday, 02/22/2024 7:37:53 PM

Thursday, February 22, 2024 7:37:53 PM

Post# of 700348
Worth a read………….. (apologies if this has already been posted)

The Vital Importance of Working in Partnership with Other Regulators – An Interview with MHRA’s CEO Dr. June Raine - 2/20/24

https://www.fda.gov/international-programs/global-perspective/vital-importance-working-partnership-other-regulators-interview-mhras-ceo-dr-june-raine

“That's the scene setting. Where are we now? We've launched our International Recognition Procedure with seven reference regulators, and it's beginning to grow as of the beginning of January this year. There are two pathways: one is a straightforward, 60-day pathway with regulators where there are few differences between our standards and theirs, and a second where the applicant may have made some changes to the original dossier, which takes longer, at 110 days. So, watch this space.”
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