漢方薬のベネフィット・リスク評価システムの構築戦略と発展の見通し

With the acceleration of the research and transformation of the regulatory science for traditional Chinese medicine(TCM), the construction of a benefit-risk assessment(BRA) system tailored to the characteristics of TCM, has become a key task in promoting the scientific and international regulation of TCM. This article summarized the research progress on BRA globally and its implications for the regulation of TCM, analyzed the unique features and regulatory challenges of BRA in the TCM context, and elaborated on a new concept of scientific regulation of TCM based on risk management, as well as a dynamic BRA regulatory model spanning the entire product life cycle. It proposed strategies for constructing the BRA system based on the characteristics of TCM, including guiding principles, indicator systems, and implementation methods. It emphasized the integration of TCM theory, long-term clinical experience, efficacy, safety, and quality evaluation, along with multidisciplinary collaboration and artificial intelligence(AI) technology, which together support the establishment of a BRA indicator system for the characteristics of TCM. The innovative concept of risk management, strategies for constructing the BRA system, and the BRA indicator system for TCM proposed herein offer new ideas and methods for the systematic evaluation of the comprehensive performance and clinical value of TCM, grounded in scientific efficacy, safety, and quality evaluation of TCM regulation. This approach facilitates the transformation of TCM regulation from traditional quality control to modern risk management. It plays an important role in accelerating the development and market approval of new TCM drugs, achieving high-level safety supervision and high-quality industry development, and promoting international regulatory coordination and the internationalization and globalization of TCM.