Analysis of Restrictive Factors and Policy Suggestions on Developing and Producing childrens drugs from the Perspective of Chinese Pharmaceutical Enterprises

Corresponding author: SHAO Rong, shaorong118@163.com

DOI: 10.12201/bmr.202403.00009

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  Abstract: Objective: To analyze the constraints on developing and producing childrens drugs from the perspective of Chinese pharmaceutical enterprises, and provide a basis for improving the design and implementation of policies for ensuring the supply of childrens medicine in China. Method: Based on literature review, identify the relevant factors that may constrain the development and production of children’s drugs in various stages of the drug lifecycle, and design a questionnaire to analyze the impact and urgency of different factors through questionnaire research. Result: The main constraints in the R D, registration review, production, and payment processes in China include: difficulty in recruiting clinical trial subjects, high safety risks, and fewer specialized pediatric clinical trial institutions; The current registration and approval rules lack consideration for the specificity of childrens drugs and specific requirements for application materials; Lack of implementation rules and measures in the implementation process of incentive and supply guarantee policies for childrens drug production; The market interest mechanism of childrens medicine is not yet perfect, and the risk return is incorrect. Among them, research and development and payment for use are currently relatively concentrated issues. Conclusion: It is recommended that China coordinate the layout and save clinical trial resources for children, and explore the sources of clinical trial data for children; Strengthen R D incentive policies such as financial support and tax incentives; Exploring the optimization path of childrens drug production and supply from typical cases, and implementing incentive measures for childrens drug production; Considering the particularity of childrens medicine, more space should be given to childrens medicine in the use and payment rules of conventional drugs.

  Key words: pharmaceutical enterprises; Childrens drugs; Research and development; Production; Supply; Constraints; policy

  Submit time: 7 March 2024

  Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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