OBJECTIVE  This study aims to analyze the current status of active pharmaceutical ingredient(API) registration and the challenges faced by the regulatory system in China from an antitrust perspective. It seeks to explore the reasons behind the frequent occurrence of monopoly cases in the API sector and their impacts, while proposing optimization recommendations to promote fair competition and ensure the stable drug supply in China's API industry.

METHODS  Utilizing publicly available data from the National Medical Products Administration and monopoly-case statistics, this research employs descriptive statistical analysis and policy text analysis to systematically investigate the current state of API registration and regulatory systems, market structure characteristics, and the underlying causes of monopolistic behaviors.

RESULTS  By the end of 2024, 48.4% of approved API varieties in China were produced by no more than three manufacturers, with 24.7% being exclusively produced by a single manufacturer. Additionally, 39.9% of API demand-side entities outnumbered suppliers, with an average ratio of 4.1∶1. The frequent occurrence of monopoly cases was primarily attributed to high entry barriers, unclear ownership, and imbalanced power structures within the supply chain, leading to price surges, weakened R&D capabilities, and unstable drug supply.

CONCLUSION  To address the monopoly dilemma and ensure drug accessibility and high-quality industry development in China, it is recommended to clarify API product ownership, reduce the approval time for supplier changes under "I status", and optimize the market competitive environment through targeted classifications.