Analysis of constraints and policy recommendations for the development of pediatric drugs in China:Based on the perspective of pharmaceutical enterprises / 中国卫生政策研究

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.

Experience and enlightenment of generic drug substitution promotion policy in drug use in typical foreign countries / 中国卫生政策研究

Objective:From the link of drug use to improve China's generic drug substitution promotion policy to provide suggestions.Methods:Literature research method was used to explore the ideas and typical measures of promoting generic drug substitution in Europe,the United States,Japan and other countries.Combined with the existing problems in the process of generic drug substitution in China,specific suggestions were put forward to improve the promotion policy of generic drug substitution in the process of drug use in China.Results and conclusions:Through the experience research of Europe,the United States,Japan and other countries,it is found that typical countries outside the region have formed the idea of"accepting generic drugs-scientific and reasonable substitution-continuous feedback and improvement"in the process of promoting generic drug substitution.It is suggested that China incorporate the opinions of doctors and patients into the generic drug substitution decision-making,establish generic drug substitution rules based on risk,strengthen the real-world data research and monitoring and evaluation of generic drug substitution,strengthen the disclosure of generic drug information and policy publicity,further improve the promotion policy of generic drug substitution in the drug use process in China,and promote the alternative use of generic drugs.