让中成药安全的 “标尺”更清晰

Core Viewpoint - The recent regulatory requirements for traditional Chinese medicine (TCM) are aimed at enhancing drug safety and promoting high-quality development in the industry, with a deadline set for July 1, 2026, for clearer labeling of contraindications and adverse reactions [1][2] Group 1: Regulatory Changes - Starting from July 1, 2026, TCM products with unclear contraindications and adverse reactions will not be approved for re-registration, raising the standardization requirements for TCM [1] - The new regulations will eliminate the "only entry" approval system for TCM, allowing for the removal of products with unclear safety risks [2] Group 2: Impact on Industry - The regulatory changes are seen as a positive force for the industry, pushing it from quantity expansion to quality prioritization, thereby fostering healthy competition [2] - The systematic restructuring of the entire TCM industry chain includes revising drug labels, regulating prices, and improving processing standards, which collectively aim to enhance the scientific validation of TCM [2] Group 3: Responsibilities of Companies - Companies are now required to take greater responsibility for drug safety and efficacy, which will compel them to address data gaps and improve post-market research [1] - To remain competitive, TCM companies must actively review their product lines, update labels promptly, and ensure compliance with safety standards [1]