龙头药企密集发声！

Core Viewpoint - The Chinese herbal medicine industry is facing a compliance challenge with over 50,000 approved traditional Chinese medicine (TCM) licenses, leading to increased industry concentration as leading companies proactively adapt to new regulations [1][2][4]. Group 1: Regulatory Changes - The National Medical Products Administration (NMPA) issued new regulations requiring that any TCM product with unclear safety information in its instructions will not be re-registered after July 1, 2026 [1]. - The new regulations provide a three-year transition period, with the actual re-registration cycle extending from three to eight years, concluding in 2031 [4]. Group 2: Company Responses - Leading companies like Guilin Sanjin and Yiling Pharmaceutical have already revised their product instructions to comply with the new regulations, ensuring that their core products are not at risk of delisting [1][5]. - Guangyu Yuan has completed the re-registration of all 104 of its production licenses by the end of 2025, indicating proactive compliance with the new rules [5]. - Dong'e Ejiao confirmed that its product instructions have been updated and approved, eliminating any potential registration issues related to safety information [7]. Group 3: Industry Outlook - The Chinese herbal medicine market is expected to grow rapidly, supported by favorable policies across various aspects such as registration, quality control, and cultural promotion of traditional medicine [5]. - The China Traditional Chinese Medicine Association has called for maintaining a high-quality development environment, addressing public concerns about potential market exits of many TCM products due to misinterpretations of the new regulations [4].