Module232025

12/05/2025

4. Development of pediatric dosage forms different from those for adults For development of dosage forms for children different from those for adults, the development can take a longer period of time than when the development of a dosage form for children is not necessary. Therefore, the development plan with this point taken into account should be confirmed by the PMDA. Planning of the Paediatric Drug Development Program during Development of Drugs for Adults

The Organisation for Professionals in Regulatory Affairs

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Regulatory Framework - Canada

• Paediatric Drug Action Plan (PDAP) introduced in 2020

• Increase the development of essential paediatric medicines • Improve access to paediatric medicines and formulations • Provide more information to people in Canada on paediatric activities and data • A six-month extension of the regulatory exclusivity period is available if the description and results of clinical trials relating to the use of an innovative drug in relevant paediatric populations is provided in a New Drug Submission or a supplementary NDS filed within 5 years of the granting of the marketing authorisation

The Organisation for Professionals in Regulatory Affairs

28