Module232025

12/05/2025

Regulatory Framework - Switzerland

• Agreed paediatric plan needed for MAA. • EU PIP or US Pediatric study plan (PSP) accepted

• 6 month paediatric supplementary protection certificate possible • SwissPEDNet – Swiss Research Network of Clinical Pediatric Hubs

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework - Japan

Japan is signatory to ICH guidance

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• No regulation mandating paediatric drug development

• Several frameworks have been implemented to enhance paediatric drug development

• Planning of the Paediatric Drug Development Program during Development of Drugs for Adults (voluntary basis) • Paediatric development in accordance with this approach attracts premium pricing rate • Marketing exclusivity extended by up to 10 years if sponsor submits a development plan for the pediatric population by the end of the review for marketing authorization and initiates planned clinical trial(s) within 2 years after marketing authorization, which could contribute to early initiation of the pediatric clinical trials. • Potential for priority for scientific advice

• PMDA Regulatory Affairs Consultation Centre dedicated to Paediatric and Orphan Drugs (est. July 2024)

• Increased calls for establishment of regulation requiring paediatric drug development

• March 2025: issued ‘initiatives to promote pediatric drug development’

The Organisation for Professionals in Regulatory Affairs

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