告别“尚不明确”！头部药企早已布局这场“中药合规赛”

Core Insights - The pharmaceutical industry is approaching a critical juncture with the impending implementation of the "Traditional Chinese Medicine Registration Management Regulations" by July 1, 2026, which will require clarity in drug labeling and safety information [1][2] Industry Overview - The "life and death clause" for traditional Chinese medicine (TCM) was officially implemented on July 1, 2023, mandating that any drug label containing "unclear" information regarding contraindications, adverse reactions, or precautions will not be re-registered after the three-year grace period ending on July 1, 2026 [2] - As of the end of 2025, there are approximately 57,000 valid TCM approval numbers in China, with over 40,000 of these lacking clear safety information, indicating a significant challenge for many products [2] Safety and Quality Transition - Concerns regarding the safety of TCM have been addressed by experts, highlighting that TCM accounts for only 12% of reported adverse drug reactions over the past five years, compared to 81% for chemical drugs, suggesting that TCM is relatively safe [3] - The new regulations aim to enhance the quality of TCM by transitioning from a focus on quantity to prioritizing quality, thereby improving the clarity and evidence-based nature of drug usage [3] Company Responses - Leading companies in the TCM sector, such as Yiling Pharmaceutical, have proactively revised their product labels to comply with the new regulations, ensuring that all necessary safety information is clearly stated [4] - Other companies like Rongchang Pharmaceutical and Buchang Pharmaceutical have also completed the necessary updates to their product descriptions, indicating a strong industry response to the regulatory changes [4] - The upcoming deadline is seen as an opportunity for compliant companies to strengthen their market position by eliminating lower-quality competitors, marking a shift towards responsible and high-quality development in the TCM industry [4]