Module232025

5/7/2025

Why Paediatric Regulation(s) Children should have the same opportunity as adults to use safe and effective medicines Medicines are primarily developed for adults /adult diseases - Economic and social reluctance for conducting clinical trials in children Physicians are comfortable making calculated guesses based on biometric conversion factors, utilising manipulation of adult formulations - The younger or the sicker the child is, the more likely it is that an unlicensed medicines will be used Lack of paediatric research to cover critical knowledge gaps in developmental pharmacology and paediatric trial methodology at a pre-competitor stage - Increased cost for drug development activities

Delay access to innovative medicines for children

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Why do we have to plan for paediatric drug development?

The introduction of US (1994), EU (2007), UK (2021) paediatric regulations mandated considering/investigating all new drugs in paediatric populations

Regulatory objectives

Increase in specifically authorised medicines for children:  High quality research into development of medicines for children  High quality information about medicines used by children  Without causing unnecessary clinical trials in children or delaying authorisation of adult medicines

It is mandatory in key marketing jurisdictions EU/UK and USA (… and the right thing to do based on science and public health needs)

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