不良反应等“尚不明确”不能注册，大量中成药将退出市场！多位业内人士：被淘汰的绝大部分是“僵尸品种”，不会影响正常供应

Core Viewpoint - The new regulations for traditional Chinese medicine (TCM) registration, effective July 1, 2026, are perceived as a "survival deadline" for TCM products, requiring clear safety information or facing market exit. However, the industry views this as an opportunity to eliminate "zombie approvals" that have little market value and are not actively sold [1][2]. Group 1: Regulatory Changes - The new regulation mandates that if any safety information in TCM product labels remains "unclear" after three years, re-registration will be denied, leading to potential market exit for those products [2][3]. - Most of the approvals likely to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with minimal or zero market sales, thus not impacting the overall market supply [2][3]. - The cost for companies to update their product information to comply with the new regulations is manageable, ranging from thousands to tens of thousands of yuan, with a registration fee of 9,600 yuan per approval [2][3]. Group 2: Industry Response - Industry insiders believe that the impact of the new regulations on total sales volume will be minimal, as many companies are already prepared for the changes and have completed re-registration for key products [4][5]. - The time frame provided by the new regulations is considered sufficient for companies to adapt, with many already having completed necessary updates for core products [6][7]. - The registration process is seen as a manageable task rather than a high-cost project, with companies able to utilize existing databases and literature to fulfill safety data requirements [5][6]. Group 3: Market Dynamics - The upcoming centralized procurement of TCM and adjustments to the national essential drug list are viewed as more significant threats to the industry than the registration regulations, with potential impacts on core product profitability [7][8]. - The centralized procurement process is expected to reshape market dynamics, as it may favor unique products while creating challenges for demonstrating clinical equivalence among similar TCM products [8][9]. - The adjustment of the essential drug list is anticipated to be a critical period for TCM companies, with significant implications for their future development and market positioning [9].