Tianjin University Leads First ISO Standard for Single-Herb TCM Formula Granules

The International Organisation for Standardisation (ISO) has issued ISO 21756:2026, the world’s first international standard for single-herb Traditional Chinese Medicine (TCM) formula granules. The standard, titled Traditional Chinese Medicine – Salvia miltiorrhiza Root and Rhizome Aqueous Extract Granules, is an important step in promoting global TCM quality harmonisation.

The standard was established in partnership with Tasly Pharmaceutical Group and China Resources Sanjiu under the leadership of Professor Gao Wenyuan of Tianjin University’s School of Pharmaceutical Science and Technology, with Professor Li Xia serving as a core member. Through numerous worldwide seminars and rigorous technical evaluations with experts from dozens of nations, the team achieved broad global support for the standard’s release.

TCM formula granules are a modernised version of traditional herbal decoctions.A decoction is a traditional method of extraction that involves boiling raw plant materials to extract their active chemical compounds.Unlike an infusion (like standard tea, where herbs are simply steeped in hot water), a decoction uses continuous boiling to break down tough, woody, or dense plant parts.

The TCM formula granules uphold the fundamental TCM principles of condition classification and personalised treatment while addressing preparation and storage issues. This format is consistent with worldwide demands for standardisation, making it more accessible and acceptable to foreign markets.

Salvia miltiorrhiza is a well-known herb with increasing international demand for its formula granules. However, the lack of standardised production processes and quality assessment criteria has long hampered the globalisation of these items.

ISO 21756:2026 addresses this gap by creating systematic requirements across the product lifecycle, from raw material traceability to finished product testing. The standard offers quantitative criteria such as characteristic chromatograms, content assays, and safety limits, establishing a single benchmark for global production. Furthermore, it provides a reproducible and scalable route to developing ISO standards for alternative single-herb formula granules.

Tianjin University, which provided the primary technical support for this standard, was heavily involved in its creation at all stages. The university’s staff consistently refined the feasibility studies and technical framework, guiding the creation of the overall technical architecture and the development of testing procedures. “We also optimised technical clauses in strict accordance with ISO rules and international pharmacopeial requirements, and led international conference defences to drive global consensus,” Gao said.

He went on to say that speeding the application of international standards for TCM formula granules not only protects international trade but also supports the global spread of TCM.

Looking ahead, the team intends to work with TCM firms and international standardisation agencies to accelerate the development of new international standards that will benefit global public health.