Core Viewpoint - The new regulations for traditional Chinese medicine (TCM) registration, referred to as the "death clause," will require that key safety information be clarified by July 1, 2026, or the products will face delisting. However, many industry insiders view this as an opportunity for the industry to eliminate "zombie approvals" that are no longer commercially viable [1][2][4]. Group 1: Regulatory Changes - The "New Regulations for TCM Registration" will take effect on July 1, 2026, mandating that any TCM product with unclear safety information will not be re-registered [2][3]. - Most of the TCM products likely to be eliminated are considered "zombie approvals," which are low-value, highly homogeneous products with minimal or zero market sales [2][4]. - The cost for updating safety information for TCM products ranges from thousands to tens of thousands of yuan, with an additional application fee of 9,600 yuan per approval [3][6]. Group 2: Industry Response - Industry experts believe that the impact of the new regulations on the overall sales volume of TCM will be minimal, as many products are already in excess supply [4][6]. - Companies are expected to take advantage of the three-year buffer period to either update their products or voluntarily abandon non-core approvals [10][11]. - The time frame for compliance is seen as generous, allowing companies ample opportunity to meet the new requirements without significant financial strain [8][10]. Group 3: Market Dynamics - The upcoming adjustments to the national essential drug list and the TCM centralized procurement process are viewed as more pressing concerns for the industry than the new registration regulations [10][11]. - The centralized procurement process, set to take place in November 2025, will involve 90 products and a market scale of over 45 billion yuan, raising concerns about future pricing and competition [11][12]. - The adjustment of the essential drug list is anticipated to be a critical window for TCM companies, with significant implications for core product viability and profitability [12].