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Official PDF TranslationChinese Journal of New Drugs

Advancing Drug Regulation and Application in China: A Comprehensive Review of the Electronic Drug Registration System

Authors: ZHANG Wei; LI Ming; WANG Fang; LIU Yang

DOI: cast_zgxyzz_1236731778740843196Status: Verified Translated Edition
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Key Findings in This Report

• The electronic drug registration system (eDRS) in China has significantly improved the efficiency and transparency of drug approvals. • Integration of eDRS with pharmacovigilance and clinical trial databases enhances post-market drug safety monitoring. • Challenges such as data standardization and interoperability remain, necessitating ongoing system optimization. • Adoption of emerging technologies like AI and blockchain can further strengthen the eDRS's integrity and security.