TIANJIN, China, Sept. 16, 2026 /PRNewswire/ — The International Organization for Standardization (ISO) has published ISO 21756:2026, the world’s first international standard for single-herb Traditional Chinese Medicine (TCM) formula granules. Titled Traditional Chinese Medicine — Salvia miltiorrhiza Root and Rhizome Aqueous Extract Granules, the standard represents a significant step forward in promoting global quality harmonization of TCM.
Led by Professor Gao Wenyuan from the School of Pharmaceutical Science and Technology at Tianjin University, with Professor Li Xia as a core member, the standard was developed in collaboration with Tasly Pharmaceutical Group and China Resources Sanjiu. Through multiple international seminars and rigorous technical reviews with experts from dozens of countries, the team forged broad global consensus for the standard’s publication.
TCM formula granules represent a modernized innovation of traditional herbal decoctions. They preserve the core TCM principles of syndrome differentiation and personalized treatment while solving preparation and storage challenges. This format aligns with global demands for standardization, making it increasingly accessible and acceptable to international markets.
Salvia miltiorrhiza is a globally recognized herb, with growing international demand for its formula granules. However, the absence of unified production protocols and quality evaluation standards has long hindered the globalization of these products.
ISO 21756:2026 fills this gap by establishing systematic regulations across the product lifecycle—from raw material traceability to finished product testing. The standard introduces quantifiable metrics, including characteristic chromatograms, content assays, and safety limits, providing a unified benchmark for global production. Moreover, it offers a replicable and scalable pathway for developing ISO standards for other single-herb formula granules.
Serving as the core technical support for this standard, Tianjin University was deeply involved in every stage of its development. The university’s team continuously refined the feasibility studies and technical framework, and guided the design of the overall technical architecture and the establishment of testing methodologies. “We also optimized technical clauses in strict accordance with ISO rules and international pharmacopoeial requirements, and led international conference defenses to drive global consensus,” Professor Gao said.
He added that accelerating the implementation of international standards for TCM formula granules not only safeguards international trade but also promotes the global dissemination of TCM.
Looking ahead, the team plans to collaborate with TCM enterprises and international standardization bodies to advance the development of additional international standards, contributing to global public health.
