Paediatric Drug Development in China: Current Status and Future Prospects

Area of Science:

• Pediatric Pharmacology
• Regulatory Science
• Drug Development

Background:

• Global regulatory agencies have long promoted pediatric drug development through guidelines and laws.
• China issued key policies in 2014 and subsequent regulations to prioritize and support pediatric medicinal product development.
• Significant progress has been made, with 172 pediatric drugs approved from 2018 to 2022.

Purpose of the Study:

• To analyze regulations promoting pediatric drug development in China.
• To review the progress of pediatric drug approval, clinical trials, and labeling in China.
• To discuss current challenges and future strategies for pediatric drug research and development in China.

Main Methods:

• Analysis of regulations including priority review and approval systems, technical guidelines, data protection, and financial support.
• Review of general profiles of pediatric drug approval and clinical trial data.
• Examination of label updates for marketed medicinal products to include pediatric information.

Main Results:

• 172 specialized pediatric medicinal products were approved between 2018 and 2022.
• Four pediatric drug lists have been issued since 2016, comprising 129 medicinal products.
• Approximately 25 listed drugs have been approved, covering areas like oncology, neurology, and rare diseases.

Conclusions:

• China has established a comprehensive regulatory framework to foster pediatric drug development.
• The implemented policies have led to a notable increase in approved pediatric medications.
• Addressing existing challenges is crucial for continued advancement in pediatric drug research and development in China.