Regulator Aims to Establish 30 National Quality Inspection Centers Under the 15th Five-Year Plan

Deep News
09/21

On September 20, the State Council Information Office convened a press conference under the "Solid Start for the 15th Five-Year Plan" series, outlining strategies to advance high-quality development in market regulation during the 2025-2030 period. The 15th Five-Year Plan framework emphasizes elevating the integration of modern services with advanced manufacturing and enhancing capabilities in inspection, testing, and certification services.

Shu Wei, spokesperson and deputy director of the State Administration for Market Regulation (SAMR), responded to a question from a reporter at the event, noting that inspection, testing, and certification are fundamental components of producer services. These services act as foundational market economy mechanisms that strengthen quality management, improve market efficiency, and facilitate trade. They provide robust support for building a modern industrial system, cultivating a strong domestic market, and expanding high-level opening-up. During the 15th Five-Year Plan period, the administration intends to establish no fewer than 30 national quality inspection centers and more than 300 public service platforms for inspection and testing.

Strengthening Credibility in the Inspection Sector

Shu Wei detailed three primary areas of focus for SAMR during the upcoming period. The first priority is enhancing the credibility of these services. Inspection, testing, and certification are essentially about conveying market trust and serve as the "letters of credit" for the market economy. To this end, SAMR will deepen reforms in the qualification approval system for inspection and certification bodies, implementing a unified list and database management approach. This includes strict oversight of mandatory product certification bodies and laboratories, while rigorously controlling market entry. The administration will also promote resource sharing, mutual recognition of qualifications, and universal acceptance of results, encouraging widespread adoption across social governance, administrative supervision, and public procurement. Additionally, a traceability and verification system featuring unified codes will be established, allowing inspection reports to be verified online with single-code tracing. A long-term mechanism will be created to combat fraudulent certification practices and the trading of certificates, with serious penalties for issuing false reports or conducting inspections beyond approved scopes.

Enhancing Industrial Support Capabilities

The second focus area involves strengthening support for industrial development. Inspection, testing, and certification are considered the "health check" for quality management, scientifically identifying product defects with precision. SAMR will expand the supply of high-quality certification services, promoting certification applications in strategic sectors such as the BeiDou navigation system and integrated circuits. Service certification in areas like elderly care and health will also be deepened. A national-level public service platform for quality inspection will be developed to rapidly advance capabilities in core components and advanced industrial infrastructure, fostering deeper integration of testing resources with industry needs. During the 15th Five-Year Plan period, the goal is to establish at least 30 national quality inspection centers and 300 public service platforms for inspection and testing.

Expanding International Influence

The third priority is boosting global influence. Inspection, testing, and certification serve as essential "passports" for international trade, enabling companies and products to access global markets smoothly. SAMR will strengthen the international alignment of testing and certification outcomes, aiming for multi-country recognition from a single evaluation to facilitate the global expansion of Chinese products. This includes advancing the "soft connectivity" action plan for conformity assessment rules and standards under the Belt and Road Initiative, promoting international proficiency testing, and implementing mutual recognition arrangements in key regions and sectors. Efforts will also focus on aligning domestic and foreign trade certification rules. The administration will actively cultivate world-class inspection and certification institutions, supporting their collaboration with domestic supply chain enterprises to venture abroad jointly, while enhancing the global voice and brand reputation of China's testing and certification systems.

Full Support for Innovative Drug Development

The biopharmaceutical industry represents a strategic emerging sector directly impacting public health and safety. Yang Sheng, deputy director of the National Medical Products Administration (NMPA), addressed how drug regulatory authorities will foster innovation and high-quality development in the pharmaceutical industry during the 15th Five-Year Plan period. He emphasized that the ultimate goal of pharmaceutical innovation is to accelerate patient access to new and effective medications. The plan period is off to a promising start, with 59 innovative drugs and 51 innovative medical devices already approved for market entry this year.

Moving forward, the NMPA will concentrate on three areas to fully support the growth of innovative drugs and devices. First, it aims to make innovation more vibrant and incentivized. Innovation requires institutional protection, so the NMPA will implement a data protection system for drug testing results and establish market exclusivity periods for pediatric and rare disease medications, ensuring companies see returns on their research investments. Communication mechanisms for early-stage research and development will be improved, offering pre-emptive guidance on drugs targeting new biological mechanisms and pathways to help streamline development. The "Spring Rain Initiative" for translating clinical innovation in medical devices will be expanded, with new guidelines for clinical trials and review processes in frontier areas like brain-computer interfaces. By concentrating top-tier review resources, the NMPA seeks to accelerate the market entry of innovative drugs and devices that are "created in China" and "new globally."

Second, the administration will work to elevate manufacturing quality and substance. Effective medications depend not only on sophisticated research but also on high-caliber production. Support will be provided for the pharmaceutical industry to scale up, consolidate, and advance toward high-end capabilities, encouraging companies to establish smart and green factories. Continued backing will be directed toward regional pharmaceutical innovation in areas like the Beijing-Tianjin-Hebei region, the Yangtze River Delta, the Greater Bay Area, and the Chengdu-Chongqing economic zone, with the goal of cultivating 3 to 5 globally competitive biopharmaceutical clusters. The NMPA will also encourage expanded openness and international cooperation in the pharmaceutical field, supporting foreign companies in localizing the production of original drugs and advanced medical equipment while also encouraging Chinese enterprises to expand globally for the benefit of patients worldwide.

Third, the focus will be on making medication supply more abundant and accessible. For clinically urgent needs, the NMPA will rationally shorten review and approval timelines and establish priority inspection fast-tracks, shifting from "people waiting for drugs" to "drugs waiting for people." Programs like the "Starlight Initiative" for pediatric oncology drug development and the "Care Initiative" pilot for rare disease treatments will be expanded to offer hope for patients with special needs. Additionally, support will be provided for upgrading generic drugs, encouraging the adoption of advanced international technologies and processes to transition generics toward higher value-added and technology-intensive products, thereby improving overall drug supply quality and ensuring public access to more and better medications.

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