Announcement
The International Organization for Standardization (ISO) has released ISO 21756:2026, titled Traditional Chinese Medicine — Salvia miltiorrhiza Root and Rhizome Aqueous Extract Granules. This is the world’s first international standard dedicated to single‑herb TCM formula granules, marking a major step toward global quality harmonisation of traditional Chinese medicinal products.
Standard Details
ISO 21756:2026 establishes systematic regulations that span the entire product lifecycle, from raw‑material traceability to finished‑product testing. It introduces quantifiable quality metrics, including characteristic chromatograms, specific content assays, and defined safety limits, thereby providing a unified benchmark for manufacturers worldwide. The standard also outlines a replicable and scalable pathway for developing future ISO standards for other single‑herb formula granules.
Development and Collaboration
The standard was developed under the leadership of Professor Gao Wenyuan from the School of Pharmaceutical Science and Technology at Tianjin University, with Professor Li Xia serving as a core member. The project was executed in close collaboration with two major Chinese pharmaceutical companies: Tasly Pharmaceutical Group and China Resources Sanjiu. The development process involved multiple international seminars and rigorous technical reviews with experts from dozens of countries, achieving broad global consensus before publication. Tianjin University’s team refined feasibility studies, designed the overall technical architecture, and established testing methodologies, while also optimising technical clauses to align with ISO rules and international pharmacopoeial requirements.
Significance and Future Plans
Professor Gao noted that the new standard not only safeguards international trade of TCM formula granules but also promotes the global dissemination of traditional Chinese medicine. Looking ahead, the team intends to work with additional TCM enterprises and international standardisation bodies to create further single‑herb ISO standards, thereby contributing to global public health and expanding the accessibility of TCM products in international markets.