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“监管差”缩小 中成药行业该警醒了
Jing Ji Guan Cha Bao· 2025-11-30 05:30
Core Viewpoint - The Chinese patent medicine industry is facing increased scrutiny and regulatory challenges, particularly regarding pricing disparities and the misuse of traditional medicine prescriptions, necessitating a shift towards genuine innovation and responsible practices [1][2][3]. Group 1: Regulatory Environment - The Tianjin Medical Insurance Bureau has initiated price risk management for 230 Chinese patent medicine varieties, revealing price discrepancies as high as 3042 times among different products [1]. - The regulatory environment for Western medicine is becoming stricter, with the National Medical Products Administration (NMPA) enforcing quality and efficacy evaluations, while Chinese patent medicine companies have been able to evade similar scrutiny [2]. - There is a growing concern about the misuse of Chinese patent medicines, with some hospitals excessively prescribing these medications, leading to calls for stricter regulations on who can prescribe them [1][2]. Group 2: Industry Challenges - The Chinese patent medicine industry has rapidly developed into a market exceeding 400 billion yuan, but it has been marred by over-marketing and misinterpretation of "integrated Chinese and Western medicine" [2]. - The reliance on "micro-innovation" and "pseudo-innovation" is becoming unsustainable as regulatory standards tighten, pushing companies to seek true innovation rather than minor adjustments to existing products [2][3]. - The era of inflated pricing and high profits for Chinese patent medicines is coming to an end, prompting leading companies to explore transitions into broader health product markets [3]. Group 3: Recommendations for the Industry - Companies are advised to move away from superficial innovations and focus on developing new medicinal materials, formulations, and delivery methods to meet stricter regulatory requirements [2][3]. - A return to the principles of "differentiated treatment" in traditional Chinese medicine is recommended, with a call for the NMPA to limit the scope of indications for Chinese patent medicines to prevent misuse [3]. - The industry should shift from being solely a medical insurance product to a broader health product, targeting preventive care for populations at risk of health issues [3].