Previously submitted to: JMIR Formative Research (no longer under consideration since Jan 19, 2026)
Date Submitted: Oct 29, 2025
Open Peer Review Period: Nov 24, 2025 - Jan 19, 2026
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Policy Evolution and Evaluation of Online Pharmacies Regulation in China: A Quantitative Analysis Based Mixed Models
ABSTRACT
Background:
Global drug shortages have posed persistent public health challenges, while internet-based drug sales have recently emerged as a promising solution, especially during the COVID-19 pandemic. However, systematic analyses of national-level regulatory policies for online pharmacies regulation remain limited.
Objective:
To explore the structure, thematic focuses, and internal consistency of China's national policies regulating online pharmacies.
Methods:
Two researchers independently retrieved and screened 22 national policies issued by Chinese government agencies by April 1, 2025, based on predefined criteria. Latent Dirichlet Allocation (LDA) was used for topic extraction, and a Policy Modeling Consistency (PMC) Index Model was constructed, incorporating literature review and focus group insights to quantitatively assess policy comprehensiveness and quality.
Results:
First, the issuance of online drug sales regulation policies in China has accelerated significantly between 2016 and 2022. Second, Latent Dirichlet Allocation (LDA) analysis categorized the 22 policies into five major thematic areas: (1) Internet Drug Trading and Health Service Management; (2) Regulation of Illegal Sales and Pharmacy Online Transactions; (3) Integration of Traditional Medicine and Treatment Data; (4) Diagnosis Qualification and Medical Institution Accreditation; and (5) Healthcare Personnel Management and Institutional Development. Third, a PMC evaluation framework was constructed, encompassing 10 primary variables and 43 secondary indicators, covering dimensions such as Policy Nature, Timeliness, Issuing Agency, Incentives and Constraints, Policy Content, and Stakeholder Protection. Fourth, the average PMC Index score was 5.04, classifying the policies as “acceptable,” with individual scores ranging from 2.45 to 6.93. Strengths were identified in regulating online drug transactions, curbing counterfeit drug incidents, enhancing traceability and recall mechanisms, protecting consumer rights, and promoting compliant online pharmacies. However, deficiencies were notable in Policy Nature, Timeliness, and Issuing Agency dimensions.
Conclusions:
While China’s regulatory efforts in internet-based drug sales have advanced, critical gaps persist. Strengthening oversight of drug circulation and storage in online transactions and mitigating risks from prescription-free drug purchases remain urgent priorities. Future policy refinements could benefit from international best practices, such as Germany’s rigorous online prescription verification systems. Clinical Trial: None
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