Abstract:China's drug patent linkage system is fundamentally designed to achieve economic and social benefits, comprising mechanisms such as patent information registration, patent declarations, and the nine-month approval waiting period. However, empirical analysis reveals several legal loopholes in the operation of the system, including irregularities in patent information registration and disorderly patent declarations; a breakdown in coordination between Type I declarations and information registration; and an imbalanced nine-month approval waiting period that is susceptible to abuse. These loopholes undermine the system's economic efficiency. To address these shortcomings, three approaches should be adopted based on an identification of the affected operational aspects and associated risks. First, establishing a preventive regulatory mechanism for patent information and declarations. Second, clarifying liability regulations for failure to fulfill the duty of care or notification regarding patent declarations. Third, creating an approval waiting period that can be flexibly adjusted or extended upon application. Thereby, these approaches would support adaptive revisions to the relevant provisions of The Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes(Trial).