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UK Explains Post-Brexit Pediatric Study Processes

MHRA Will Ask For UK-Relevant Info Such As Unmet Therapeutic Need

 
• By Vibha Sharma

The Medicines and Healthcare products Regulatory Agency has outlined the various common scenarios that may occur when companies submit a UK pediatric investigation plan after the Brexit transition period has expired.

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MHRA Says It Will Simplify Application Process For Pediatric Studies • Source: Shutterstock

The UK medicines regulator has issued three guidelines explaining the procedures it is putting in place to deal with national pediatric investigation plans (PIPs) when the transition period after Brexit comes to an end this year.

The guidelines cover the processes to be followed by companies from 1 January 2021 when submitting a UK PIP...

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