Module232025

12/05/2025

Regulatory Framework - Canada

• Effective 26 February 2024: Health Canada (HC) Pilot on Peadiatric Development Plans and Studies • Expected to run for 2 years: encourages sponsors to submit pediatric studies for drugs approved for adults in Canada • Voluntary; applicable to all new drug submissions (NDS) and certain supplements to a new drug submission (SNDS) • include a paediatric development plan (PDP) • fill out policy survey • Sponsors with no EU-PIP or US PSP can submit a Canadian pediatric development plan (C-PDP) Pilot on pediatric development plans and studies

• Subject to HC transparency initiatives

Annual reports required

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• Guidance on submitting pediatric development plans and pediatric studies

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework - WHO

• WHO Paediatric Regulatory Network • Support the availability of quality medicines for children through facilitation of communication, collaboration, training and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medicines • GAP-f Global Accelerator for paediatric formulation • Spur collaboration across stakeholders to identify gaps, set priorities for needs and accelerate product investigation, development and delivery to improve and save the lives of children • Identified antibiotics to treat infections in children caused by pathogens on the WHO Bacterial priority pathogen list with an approved paediatric indication, but for which age-appropriate formulations are missing and should be given priority for development. • to be investigated and developed within a time horizon of three to five years • identified promising antibiotic candidates for investigation in children that are currently under clinical development (or already approved), but without a specific paediatric indication. • to be investigated and developed within a time horizon of five to ten years • potential framework for expedited evidence generation identified

The Organisation for Professionals in Regulatory Affairs

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