Spring Intro 2023

16/02/2023

Problem

• Children are generally a fit and healthy bunch • Commercially uninteresting • Historically neglected in terms of medicines development • Paediatric drugs therefore largely used off-label with “guess-work” doses

• Legislation was brought in to ensure paediatric needs are taken into account

Regulation (EC) 1901/2006

The Organisation for Professionals in Regulatory Affairs

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Legislation scope

• Mandatory • Drugs which are not yet authorised • Authorised drugs which are still under patent where the objective is: • New indication

• New route of administration • New pharmaceutical form

• Optional • Off-patent drugs where the intention is to seek authorisation in children only (PUMA)

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The Organisation for Professionals in Regulatory Affairs

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