大批中成药将退出市场吗？丨快问快答

Core Viewpoint - The upcoming implementation of the "Special Regulations on the Registration Management of Traditional Chinese Medicine" will not lead to a mass exit of traditional Chinese medicine (TCM) products from the market, but rather an orderly withdrawal of non-compliant varieties [2]. Group 1: Market Impact - There will not be a "mass exit" of TCM products; instead, non-compliant varieties will exit in an orderly manner [2]. - The policy targets the re-registration phase of TCM, meaning that products with expired approval numbers must reapply, rather than directly eliminating currently sold products [2]. - It is expected that the number of market products will decrease by 30% to 40%, focusing on "zombie approvals" and low-quality varieties that lack clinical value and safety data [2]. Group 2: Safety of Existing Products - Existing TCM products can be used normally, as the policy aims to address the shortcomings in safety information on product labels rather than questioning the clinical value of TCM [3]. - The policy specifically targets the re-registration phase, ensuring that current stock and products on the market remain compliant and unaffected [3]. - Leading companies in the TCM sector have already invested in supplementing safety evaluation data, allowing them to successfully revise product labels [3]. Group 3: Pricing Trends - There will not be a widespread price increase; instead, prices will become more reasonable and transparent [4]. - Price regulation is being enforced, with several provinces implementing a tiered management system for TCM prices to eliminate excessive pricing and disparities [4]. - The fourth batch of TCM centralized procurement has begun, which includes OTC products and some exclusive varieties, potentially leading to an average price reduction of over 40% for TCM [4].