中药注射剂迎来“大淘汰”时代

Core Viewpoint - The National Medical Products Administration (NMPA) of China is accelerating the post-marketing research and evaluation of traditional Chinese medicine (TCM) injections, signaling a push for improved safety and efficacy standards in the industry [1][5][9]. Regulatory Developments - The NMPA, along with the National Health Commission and the State Administration of Traditional Chinese Medicine, has drafted a proposal to enhance post-marketing research for TCM injections, which is currently open for public consultation [1][5]. - A "淘汰令" (elimination order) has been introduced, stating that TCM injections that do not comply with research and evaluation requirements may face deregistration or cancellation of their drug registration certificates [5][7]. Industry Context - TCM injections have been controversial in China, with a history of safety concerns, including reported deaths following their use. The NMPA has highlighted the need for ongoing monitoring and evaluation of these products [3][5]. - The market for TCM injections has grown significantly, with annual sales exceeding 100 billion RMB, indicating a substantial commercial scale despite regulatory scrutiny [3][9]. Product Focus - The proposal prioritizes TCM injections listed in the National Essential Medicines List and the National Medical Insurance Catalog, such as Qingkailing Injection and Heduoning Injection, for post-marketing research [6][7]. - The National Essential Medicines List includes 10 TCM injections, while the National Medical Insurance Catalog includes 58, indicating a broad scope for evaluation [7]. Market Impact - The acceleration of post-marketing research may lead to the exit of less viable products from the market, promoting a competitive environment that favors high-quality offerings [8][9]. - Major TCM injections have historically generated significant revenue, with products like Qingkailing Injection projected to exceed 1 billion RMB in sales in 2024 [9][11]. Historical Context - Previous regulatory actions have included the proposal to eliminate certain TCM injection products, reflecting ongoing efforts to ensure safety and efficacy in the market [12][13].