Analysis of constraints and policy recommendations for the development of pediatric drugs in China:Based on the perspective of pharmaceutical enterprises
10.3969/j.issn.1674-2982.2024.02.009
- VernacularTitle:我国儿童药研制的制约因素分析及政策建议
- Author:
Rui-Lin DING
1
;
Ming-Yu BAI
;
Jia-Nan FU
;
Xin-Yu LI
;
Rong SHAO
Author Information
1. 中国药科大学药品监管科学研究院/国家药品监督管理局药品监管创新与评价重点实验室 江苏南京 211198
- Keywords:
Pharmaceutical enterprises;
Pediatric drugs;
Research and development;
Constraints;
Policy
- From:
Chinese Journal of Health Policy
2024;17(2):59-65
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To provide a basis for improving the design and implementation of policies for ensuring the supply of pediatric drugs in China.Method:Based on the perspective of pharmaceutical enterprises,reviewed literature and conducts questionnaire surveys to identify the constraints in the development of pediatrict drugs throughout the entire drug lifecycle,and analyzes the constraints'concentration and urgency.Result:The main constraints include:difficulty in conducting clinical trials for children;the current registration and approval rules lack consideration for the specificity of pediatric drugs and specific requirements for application materials;lack of implementation rules and measures in the implementation process of incentive policies for pediatric drug production;The market interest mechanism of pediatric drugs is not yet perfect.Among them,research and development and payment for use are currently relatively concentrated issues.Discussion and suggestions:It is recommended that China fully utilize existing clinical trial data of pediatric and broaden sources,take multiple measures to increase investment in pediatric drug R&D;Develop special guidelines for pediatric drug application and encourage adult drug registration to submit pediatric research plans;Explore the optimization path of pediatrict drug production and supply based on typical cases;Provide more space for pediatric drugs in the rules of drug use and payment.
