The Design and Practical Path of Cross-Border Traceability System for Medicinal and Chemical Products — A Multi-Dimensional Empirical Study Based on Blockchain and Internet of Things

Abstract

In the cross-border trade of medicinal and chemical intermediates, industry pain points such as information silos leading to traceability disruption, low credibility of quality control data, and poor regulatory coordination efficiency are prevalent, with small and medium-sized trading enterprises being particularly affected. This study takes norfloxacin and cefotaxime active ester as typical research objects, integrating the tamper-proof characteristics of blockchain with the real-time perception technology of the Internet of Things (IoT) to construct a lightweight cross-border traceability system covering the entire chain from production to storage, logistics, customs clearance, and terminal use. The system is based on a “three-layer, nine-module” structure. An empirical test was conducted using the trade data of Wuhan Kuda Hui Trading Co., Ltd. from 2022 to 2024. The results indicate that the system can increase the completeness of traceability information to 99.2%, raise the customs clearance rate in the EU to 96%, shorten the quality control abnormal response time to 2.5 hours, and reduce the cross-border delivery cycle to 28 days. Additionally, the “three-stage promotion” low-cost practical path designed for small and medium-sized trading enterprises ensures feasibility and cost controllability, with strong replicability. The study provides a quantifiable and implementable technical solution and practical paradigm for cross-border traceability of medicinal and chemical products, effectively solving the core industry pain points.