LIU Zhihan 1,2,3 , CAO Rui 1,2,3 , SU Chengyuan 1,2,3 , GUAN Xinmiao 1,2,3 , TAO Yunci 1,2,3 , LUO Minjing 4,5 , FEI Yutong 1,2,3
  • 1. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
  • 2. International Institute of Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
  • 3. Beijing GRADE Center, Beijing 100029, P. R. China;
  • 4. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
  • 5. Guangdong Academy of Traditional Chinese Medicine, Guangzhou 510120, P. R. China;
FEI Yutong, Email: feiyt@bucm.edu.cn
Chinese patent medicines; Drug instructions; Policy tools; Policy analysis
10.7507/1672-2531.202407187
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Objective  The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods  The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results  The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion  Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.

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