基于 WTO 通报的国际贸易中药品管控措施趋势分析与应对

摘要：

本文深入剖析了2019-2023年中国药品出口贸易的发展态势，指出出口额激增后趋于稳定，出口市场以欧美为主导，化学制剂出口稳步增长，但面临产业链转移和管控趋紧的双重挑战。文章系统梳理了国际市场药品管控措施情况，并着重研究重点出口市场的管控措施特点。进一步分析了管控措施的发展趋势，措施数量增多、监管要求趋紧、数字技术推动药品监管向智能化转型。最后，文章提出了应对建议，包括优化药品法规体系、完善出口预警机制、建立药品监管沙盒、规范数字化追溯系统、推进数字贸易平台等，旨在为中国药品出口提供战略指导和决策支持。

Abstract:

This paper makes an in-depth analysis of the development trend of China’s pharmaceutical export trade from 2019 to 2023. It points out that after a surge in export volume, it tends to stabilize with European and American markets leading exports and chemical agent exports steadily increasing. However, it faces the dual challenges of industrial chain transfer and tightening control. The paper systematically reviews the situation of drug control measures in the international market, with a focus on studying the characteristics of control measures in key export markets. Further analysis is conducted on the development trend of control measures, including an increase in the number of measures, tightening regulatory requirements, and digital technology driving the transformation of drug regulation towards intelligence. Finally, the paper proposes corresponding suggestions, including optimizing the drug regulatory system, improving export warning mechanisms, establishing a drug regulatory sandbox, standardizing digital traceability systems, and promoting digital trade platforms, aiming to provide strategic guidance and decision-making support for Chinese drug export enterprises.

基金项目：本文受江苏省市场监管局科技计划项目“发达国家食药行业市场监管措施与模式研究”（项日编号：KJ2022064）资助。

作者简介：汪洋，工程师，主要研究方向为药品监管。朱峰，通信作者，正高级工程师，主要研究方向为标准化和质量管理。庞淑婷，正高级工程师，主要研究方向为标准化和技术性贸易措施。刘颖，正高级工程师，主要研究方向为标准化和技术性贸易措施。