大批中成药将退出市场

Core Viewpoint - The new regulations from the National Medical Products Administration (NMPA) will lead to the elimination of a significant number of traditional Chinese medicine (TCM) products from the market, with over 70% of existing approvals facing potential cancellation due to safety information issues [2][11]. Regulatory Changes - The "death clause" for TCM, effective from July 1, 2023, mandates that any product with unclear safety information in its instructions will not be re-registered after three years [2]. - The NMPA has already begun revising product instructions, requiring core safety information to be added to many commonly used TCM products [4]. - A new regulation on TCM production supervision will take effect on March 1, 2026, raising industry entry barriers and imposing stricter requirements on the entire supply chain [4]. Industry Impact - The TCM industry is experiencing a stark divide, with leading companies like Baiyunshan generating revenues of 61.606 billion yuan, while smaller firms struggle with revenues around 6 million yuan [6]. - The cost of compliance for smaller firms is substantial, with estimates suggesting that a traditional TCM product may require an investment of 20 million yuan over three years to meet safety data requirements [6]. - Major companies are proactively streamlining their product lines and focusing on core products, while many smaller firms are left with difficult choices regarding their market presence [6][12]. Market Dynamics - The regulatory changes are expected to lead to a significant consolidation in the TCM market, with predictions that 30% to 40% of TCM approvals may exit the market within the next 3 to 5 years [11][12]. - The dual approach of price regulation and re-registration requirements is tightening the market for low-quality TCM products, further reducing their viability [9][10]. - The future TCM market will likely see increased entry barriers, with only products demonstrating clinical value being supported by insurance [12]. Strategic Responses - Companies are advised to focus on three main strategies: conducting real-world studies to support safety data, applying for new drug status for promising products, and voluntarily canceling low-value approvals [12]. - The industry is expected to prioritize quality over quantity, with a shift towards products that can withstand scientific scrutiny and meet patient needs [12].