Office of Paediatric Initiatives

Children (ages 0-18 years) along with pregnant and nursing women have unique health and safety needs, and respond differently to health products and food than the general population. However, because it is often difficult to obtain scientific data on children, pregnant and nursing women, many foods and health products are not formulated specifically for use by this population, and may not have sufficient information on the label to guide their use. For further information, please refer to Focusing on Paediatric and Maternal Health.

Created in 2005, the Office of Paediatric Initiatives provide a focal point within the Health Products and Food Branch (HPFB) for an integrated approach on a range of science and regulatory activities that affect children and pregnant and nursing women. The Initiative strengthens HPFB's day-to-day activities around food, nutrition and health products, like medicines, to better protect and promote the health and safety of these unique populations.

The Initiative will help contribute to Health Canada's overall transition to a life-cycle approach for regulating health products and food, as outlined in the Progressive Licensing Project for Drugs and Health Products and the Regulatory Modernization Strategy for Food and Nutrition.

The Initiative fulfills its mandate by:

• Coordinating the development of paediatric information (through the regulatory system and/or other means)
• Coordinating how this information is made available and accessible
• Raising awareness of child and maternal health needs and safety issues related to the development and use of health products and food
• Promoting conditions that enable Canadians to make informed decisions about the health and nutrition of infants, children, youth, pregnant and nursing women.

This initiative focuses on health products and food which includes the following:

• pharmaceuticals
• biological, including vaccines and biotechnical products
• medical devices
• natural health products
• vaccines
• food, nutrients and additives

Additional Resources

• Contact the Office of Paediatric Initiatives
• Focusing on Paediatric and Maternal Health
• Paediatric Expert Advisory Committee

Related Resources

Government Websites and Activities

• Canada's Food Guide
• Cough and Cold Medicine for Children
• First Nations and Inuit Health Branch (FNIHB)
  • Healthy Child Development
• Healthy Pregnancy and Babies
• International Conference on Harmonization document (ICH E11): Clinical Investigation of Medicinal Products in the Paediatric Population
• Notice of Revised FDA Regulations: Paediatric data protection extension
  • Data Protection under C.08.004.1 of the Food and Drug Regulations
• Prenatal Nutrition
• Public Health Agency of Canada (PHAC):  Child Health
• Report Adverse Reactions (Side Effects) to Health Products

External Websites

•  Canadian Paediatric Society
•  European Medicines Agency - Medicines for Children
•  The Maternal, Infant, Child and Youth Research Network (MICYRN)
•  Motherisk
•  United States Food and Drug Administration - Pediatric Drug Development