大批中成药将退出市场？业界认为受影响的主要是“僵尸”批文品种

Core Viewpoint - The implementation of the "zombie" approval document regulation by the National Medical Products Administration (NMPA) is expected to lead to the elimination of over 70% of existing traditional Chinese medicine (TCM) approvals that have safety information marked as "unclear" after a three-year grace period, significantly impacting the market [1][3][5]. Group 1: Regulatory Changes - The "Special Regulations on the Registration of Traditional Chinese Medicine" issued by the NMPA aims to promote the innovation and development of TCM, emphasizing the importance of clinical value and risk assessment in drug registration [3][4]. - Article 75 of the regulation states that any TCM with unclear safety information in its instructions will not be re-registered after three years from the regulation's implementation date, which began on July 1, 2023 [1][3]. Group 2: Industry Response - Many TCM companies reported that the impact of the new regulation is minimal, as they have already begun to improve the safety information in their product instructions [4][5]. - A significant number of TCM companies have identified around 40 products that require updates to their safety instructions, with plans to complete the re-registration process by 2030 [4][5]. Group 3: Market Implications - The regulation primarily affects "zombie" approval documents, which refer to products that have been registered but are no longer produced or sold, lacking necessary safety monitoring data [1][5]. - The overall market impact is expected to be limited for actively marketed TCM products, as companies are likely to prioritize the re-registration of their key products [5][6]. Group 4: Safety Monitoring Data - The National Adverse Drug Reaction Monitoring Center reported that in 2024, there were 2.866 million adverse drug reaction reports, with TCM accounting for 12.1% of these incidents [5][6]. - The proportion of serious adverse reactions related to TCM is lower than that of chemical drugs, indicating a need for continued attention to safety in TCM usage [6].