doi: 10.3389/fphar.2025.1602976 Received 30 March 2025 Revised 13 November 2025 Accepted 14 November 2025 Published 19 December 2025 Volume 16 - 2025 Edited by Bernd Rosenkranz, Fundisa African Academy of Medicines Development, South Africa Reviewed by Kacper Nijakowski, Poznan University of Medical Sciences, Poland Miriam Njoki Karinja, Science for Africa Foundation, Kenya Updates Copyright 2025 Mazur, Ndokaj, Salerno, Vallone, Ardan, Bietolini, Carrouel, Wilk, Sarig, Ottolenghi and Bourgeois
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The MHRA ( Medicines and Healthcare products Regulatory Agency ) has two main application procedures: Simple Reclassification : This is a straightforward and quick procedure based on an analogous product (a medicinal product already on the UK market with the same active ingredient, route of administration, use, and a similar or higher strength/dosage)
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