《标准物质管理办法》正式公布，“标准”厂商迎来黄金窗口！

Core Viewpoint - The article discusses the release of the "Standard Material Management Measures" by the State Administration for Market Regulation, marking the most significant revision in 40 years, with a new three-tier management system being implemented [2][3]. Background of the Measures - Standard materials serve as the "ruler" and "weight" in chemical and biological testing activities, acting as key metrological public products and foundational strategic scientific resources. The existing management measures have been in place for nearly 40 years and are no longer suitable for the new demands and technologies emerging in the industry, necessitating a comprehensive revision and elevation to departmental regulations [4]. Key Aspects of the Revision - The revision focuses on four main areas: 1. Clarification of the concept of standard materials, emphasizing their technical characteristics such as uniformity, stability, traceability, and uncertainty [5]. 2. Transition from a two-tier management model to a three-tier model, categorizing standard materials into national benchmark materials, first-level standard materials, and second-level standard materials [5]. 3. Improvement of management systems, specifying the classification criteria for each level of standard materials and standardizing the planning and management of national benchmark materials [5]. 4. Strengthening the responsibilities of relevant entities, requiring certified organizations to ensure production supply, quality traceability, and ongoing management [5]. Transition to a Three-Tier Management Model - The shift to a three-tier management model aims to enhance alignment with other management measures and international standards. This new structure allows for more precise and effective regulation, addressing the significant differences between benchmark standard materials and traditional metrological benchmark devices [7]. Institutional Arrangements for Business Environment Optimization - The measures include: 1. Establishing an administrative approval system for standard materials, delegating the approval authority for second-level standard materials to provincial market regulation departments, thus reducing approval times and costs for enterprises [8]. 2. Introducing a commissioned production system to address the mismatch between research capabilities and production capacity, allowing organizations with core technologies to commission qualified entities for production [8]. Promotion of High-End Standard Material R&D and Technological Innovation - The measures encourage original innovation by facilitating a "green channel" for urgent and unprecedented national benchmark materials and first-level standard materials, guiding resources towards high-end fields [9]. - They also simplify the classification process for internationally recognized standard materials, promoting domestic institutions to align with global standards and integrate into advanced industrial chains [9]. Regulations on Imported Standard Materials - The measures stipulate that imported standard materials must be certified by foreign entities or their designated agents within China, ensuring equal treatment for foreign and domestic enterprises and providing a clear operational pathway for foreign businesses [10][11]. Current Issues in the Standard Material Market - The market faces challenges such as inadequate responsibility among production institutions, the presence of unlicensed low-cost or counterfeit standard materials, and outdated standards remaining in circulation. The new measures address these issues by: 1. Establishing a five-year validity period for classification certificates, ensuring dynamic updates and clear information for regulatory purposes [11]. 2. Reinforcing the responsibilities of certified organizations and requiring compliance from users to enhance product quality [11]. 3. Implementing a comprehensive regulatory mechanism that covers pre-approval, precise regulation during production, and legal enforcement post-incident [12]. Benefits for Standard Material Manufacturers - The measures provide several advantages for manufacturers, including: 1. Clear market entry and qualification pathways, defining classification criteria and application processes for different levels of standard materials [13]. 2. Establishing a tiered management system that enhances market authority and price differentiation for various standard materials [13]. 3. Encouraging innovation through expedited approval processes for urgently needed materials [13]. 4. Allowing commissioned production to optimize resource allocation and facilitate large-scale production [13][14]. 5. Providing a stable market outlook with a five-year certificate validity and renewal mechanism [14]. 6. Establishing legal import and agency channels for standard materials, ensuring compliance and operational clarity for importers [14].