中药合规
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告别“尚不明确”!头部药企或早已布局这场“中药合规赛”
Zheng Quan Ri Bao Zhi Sheng· 2026-02-01 11:06
Core Viewpoint - The pharmaceutical industry is preparing for a significant regulatory change with the upcoming deadline of July 1, 2026, for the implementation of the "Special Regulations on the Registration Management of Traditional Chinese Medicine" [1][3] Group 1: Regulatory Changes - The "life-and-death clause" for traditional Chinese medicine (TCM) was officially implemented on July 1, 2023, which states that any drug registration with "unclear" information in the sections of contraindications, adverse reactions, or precautions will not be re-registered after three years [3][4] - As of the end of 2025, there are approximately 57,000 valid TCM registration numbers in China, with over 40,000 having missing safety information [3][4] Group 2: Industry Response - Leading companies like Yiling Pharmaceutical and Rongchang Pharmaceutical have proactively completed the necessary revisions to their product labels, ensuring compliance with the new regulations [5] - Yiling Pharmaceutical has revised the labels of all 17 patented TCM products to include clear statements on contraindications, adverse reactions, and precautions [5] - Rongchang Pharmaceutical has also updated its product labels for better consumer understanding and has received approvals for age-appropriate modifications [5] Group 3: Safety and Quality - The new regulations aim to address the safety information gaps in TCM product labels, promoting high-quality development in the industry [4][6] - Data from the past five years indicates that TCM accounts for only 12% of reported adverse drug reactions, compared to 81% for chemical drugs, suggesting that TCM is relatively safe [4] Group 4: Market Implications - The impending regulatory changes are seen as an opportunity for compliant companies to strengthen their market positions by eliminating low-quality competitors [5][6] - The transition from a focus on quantity to quality in the TCM industry is viewed as a necessary evolution for sustainable growth [4][6]