2022年全国中药材及饮片质量分析概况

2022年初,国务院办公厅发布的《“十四五”中医药发展规划》中提出加强中药安全监管、提升中药质量评价能力、建立健全中药质量全链条安全监管机制、加强中药饮片源头管理等,为推动中药产业高质量发展提出了明确的要求。2022年,在国家药品监督管理局和各省药品监督管理部门的领导、组织下,汇总全国中药材及饮片的抽检结果,对全国31个省、自治区、直辖市抽检数据进行梳理并对总体质量情况进行分析,总体合格率为98%。针对质量和标准问题提出相关的监管策略与建议,为提高中药材及饮片标准,提升监管效力、监管水平提供大数据支持。

Quality Overview of Chinese Medicinal Materials and Decoction Pieces in 2022

In early 2022, the State Council''s General Office issued the 14^th Five-Year Plan for Traditional Chinese Medicine Development, which outlines specific requirements to strengthen the safety regulation of Chinese medicine, enhance the capability to evaluate Chinese medicine quality, establish a comprehensive Chinese medicine quality safety supervision mechanism, and strengthen the management of the sources of Chinese medicine decoction pieces, aiming at promoting the high-quality development of the Chinese medicine industry. In 2022, under the leadership and organization of the National Medical Products Administration and provincial drug supervision and management departments, the nationwide results of inspections of Chinese medicinal materials and decoction pieces continued to be summarized. The data from inspections conducted in 31 provinces, autonomous regions, and municipalities were analyzed to assess the overall quality situation, the overall pass rate was 98%. Relevant regulatory strategies and recommendations were proposed to address quality and standard issues, thereby providing big data support to improve standards of Chinese medicinal materials and decoction pieces and enhance regulatory effectiveness and capabilities.