中成药规范化
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让中成药安全的 “标尺”更清晰
Mei Ri Shang Bao· 2026-01-31 22:27
Core Viewpoint - The recent regulatory requirements for traditional Chinese medicine (TCM) are aimed at enhancing drug safety and promoting high-quality development in the industry, with a deadline set for July 1, 2026, for clearer labeling of contraindications and adverse reactions [1][2] Group 1: Regulatory Changes - Starting from July 1, 2026, TCM products with unclear contraindications and adverse reactions will not be approved for re-registration, raising the standardization requirements for TCM [1] - The new regulations will eliminate the "only entry" approval system for TCM, allowing for the removal of products with unclear safety risks [2] Group 2: Impact on Industry - The regulatory changes are seen as a positive force for the industry, pushing it from quantity expansion to quality prioritization, thereby fostering healthy competition [2] - The systematic restructuring of the entire TCM industry chain includes revising drug labels, regulating prices, and improving processing standards, which collectively aim to enhance the scientific validation of TCM [2] Group 3: Responsibilities of Companies - Companies are now required to take greater responsibility for drug safety and efficacy, which will compel them to address data gaps and improve post-market research [1] - To remain competitive, TCM companies must actively review their product lines, update labels promptly, and ensure compliance with safety standards [1]
让中成药安全的“标尺”更清晰
Xin Lang Cai Jing· 2026-01-30 17:41
Core Viewpoint - Recent regulatory requirements for traditional Chinese medicine (TCM) aim to enhance the safety and clarity of drug information, addressing consumer concerns about the potential elimination of many TCM products [1][2] Group 1: Regulatory Changes - Starting from July 1, 2026, TCM products with unclear contraindications, adverse reactions, and precautions will not be approved for re-registration, raising the standards for TCM safety [1] - The new regulations will end the previous system where TCM approvals were only additive, promoting a competitive environment that prioritizes quality over quantity [2] Group 2: Industry Impact - The requirement for clearer labeling will provide scientific guidance for doctors and improve public awareness of medication risks, thereby enhancing the overall safety of TCM usage [1] - The regulatory changes are expected to drive a systemic transformation across the entire TCM industry, from drug labeling to pricing and production standards, fostering a shift towards evidence-based practices [2] Group 3: Corporate Responsibility - Companies are now compelled to take greater responsibility for drug safety and efficacy, necessitating the improvement of safety data and the revision of product information [1] - The emphasis on quality and safety will encourage TCM enterprises to strengthen post-market research and ensure compliance with updated standards [1][2]