On November 20, 2025, the State Administration for Market Regulation (SAMR) issued Decree No. 106 and promulgated the Measures for the Administration of Reference Materials (hereinafter referred to as the Measures), which shall come into force on December 1, 2026.

I. What is the background for the promulgation of the Measures?

Reference materials serve as the "yardsticks" and "weights" for value traceability in testing activities such as chemistry and biology, and are key metrological public goods and basic strategic scientific and technological resources. With the vigorous development of China's reference material industry, new technologies and models are emerging one after another, posing higher and more urgent requirements for the capacity building and administration of reference materials. However, the current Measures for the Administration of Reference Materials, a normative document that has been implemented for nearly 40 years, can hardly adapt to the new situation and requirements and is of a too low legal rank, thus requiring a comprehensive revision and elevation to a departmental regulation.

II. What are the main revision aspects of the Measures?

The revisions mainly cover the following four aspects:

1. Clarify the concept of reference materials and emphasize their technical characteristics such as homogeneity, stability, traceability and uncertainty.

2. Adjust the classification of reference materials, changing the original two-tier administration model of Grade 1 and Grade 2 reference materials to a three-tier one comprising national primary reference materials, Grade 1 reference materials and Grade 2 reference materials.

3. Improve the administration system, specify the grading criteria for reference materials at all levels, standardize the planning and administration of national primary reference materials as well as the licensing administration of Grade 1 and Grade 2 reference materials, and define the valid period of the reference material grading certificate as five years.

4. Strengthen the primary responsibilities of relevant entities, requiring certified institutions to fulfill their responsibilities for production and supply, quality traceability and ongoing management, and meanwhile laying down clear requirements for production, use and entrusted entities.

III. Why does the Measures adjust the administration of reference materials from a two-tier model to a three-tier one?

First, to enhance alignment with other administrative measures. Although the Measures for the Administration of Metrological Primary Standards incorporates primary reference materials into the scope of metrological primary standards, they differ significantly from traditional metrological primary standard devices composed of hardware and thus cannot be fully governed by the same set of administrative norms. Therefore, the Measures establishes a dedicated administration form for them, namely "national primary reference materials", to achieve precise and effective supervision.

Second, to enhance alignment with international rules. ISO Guide 99, International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM), clearly defines reference materials as a type of measurement standard, which is classified into three levels: primary (benchmark) measurement standards, secondary measurement standards and working measurement standards. This classification is well aligned with the three-tier administration model in the Measures in terms of classification principles and main applications.

IV. What institutional arrangements has the Measures made to optimize the business environment and support the development of enterprises, especially private enterprises?

First, improve the administrative approval system for reference materials. At present, the industrial demand for Grade 2 reference materials is robust, and most of them are developed and produced by enterprises. The Measures explicitly delegates the administrative approval authority for Grade 2 reference materials from SAMR to provincial market supervision departments, which greatly shortens the approval time limit, reduces the institutional transaction costs of enterprises, and helps foster a world-class business environment that is market-oriented, law-based and internationalized.

Second, establish an entrusted production system for reference materials. In response to the structural contradiction where some R&D institutions have strong technical capabilities but lack production capacity while manufacturing enterprises have sufficient production capacity but are short of technologies, the Measures sets up an entrusted production system. It permits institutions mastering core technologies (entrustors) to entrust qualified entities with corresponding production conditions and quality assurance capabilities (trustees) for production in accordance with the law. This system effectively promotes the optimal allocation of technical resources and production capacity, smooths the transformation channel of advanced scientific and technological achievements into national reference materials, and accelerates the commercialization and large-scale production of innovative achievements.