Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

British journal of clinical pharmacology(2023)

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摘要
The authorization availability of novel medicines for children is lower in countries without paediatric regulatory obligations. Paediatric formulations often do not reach other countries if left unregulated, and their generic uptake is low. To increase authorization availability, submission of paediatric development results should become obligatory in each jurisdiction. Policy initiatives to stimulate the introduction of developed formulations should be encouraged.
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关键词
access to medicines,age-appropriate formulations,authorization availability,medicines for children
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