NMPA Pharmaceutical and Medical Device Review and Inspection Jing-Jin-Ji Branch Launches 'Doorstep' Services to Accelerate Innovation in Beijing

On the afternoon of October 15, the Beijing-Tianjin-Hebei Branch Center for Drug and Medical Device Evaluation and Inspection of the National Medical Products Administration (NMPA), located in the Beijing Economic-Technological Development Area, was actively providing consultation services. Pharmaceutical companies within the jurisdiction engaged in face-to-face discussions with professional evaluators on key technical issues, review processes, and other matters related to product development and registration applications.

It is reported that on September 21, the Beijing-Tianjin-Hebei Sub-center was officially unveiled and commenced operations. Leveraging the “Three Major Centers,” linking with the “Four Service Stations,” fully capitalizing on the “Three Key Advantages,” and striving to build “Three Platforms,” the sub-center aims to further improve the three-dimensional service network for the capital’s biopharmaceutical industry. By providing high-quality, efficient, and proactive services along with regulatory review and inspection support, it will assist Beijing in establishing a forefront of pharmaceutical innovation and inject robust momentum into the high-quality development of the capital’s pharmaceutical industry.

A robust industry requires strong regulatory oversight and technical support. The establishment of the Beijing-Tianjin-Hebei Sub-center in Beijing to better serve regions including Beijing, Tianjin, Hebei, and Shandong is a significant measure for deeply implementing the coordinated development strategy for the Beijing-Tianjin-Hebei region. It also constitutes a key component in fulfilling national requirements to encourage innovation in pharmaceuticals and medical devices and to promote industrial structural adjustment. This initiative will undoubtedly facilitate technological innovation in medicine and health across these four regions and empower high-quality industrial development.

The establishment and operation of the Beijing-Tianjin-Hebei Sub-Center will create a three-dimensional service network for the pharmaceutical industry, structured as “3+1+4+N,” linking the National Medical Products Administration’s (NMPA) “Three Major Centers,” relevant functional departments of the Beijing Municipal Government, and four drug and medical device innovation service stations. This initiative will significantly accelerate the efficiency of drug and medical device review and approval in Beijing. The Beijing-Tianjin-Hebei Sub-Center assists the NMPA’s Center for Drug Evaluation (CDE), Center for Medical Device Evaluation (CMDE), and Center for Food and Drug Inspection (CFDI) in comprehensively providing technical services—including pre- and mid-stage R&D guidance, consultation acceptance, and review communication for drugs and medical devices—and undertakes tasks such as registration inspections and rotational inspections.

On this basis, it will effectively integrate Beijing’s review and approval functional departments with existing service institutions. Beijing pioneered the establishment of provincial-level innovation service stations for drugs and medical devices nationwide, as well as the first national-level medical device innovation service station jointly built by drug regulatory and science and technology authorities. Currently, four branches operate in Yizhuang, Changping, Daxing, and Haidian, forming a coordinated and comprehensive service network. By providing face-to-face, precision services through thematic training, customized consulting, proactive support, resource matchmaking, topic-specific research, and industrial park collaboration, it has become an important platform and window for serving biomedical enterprises in Beijing. The operation of the Beijing-Tianjin-Hebei Sub-Center will “build bridges and pathways” between central and local functional departments and service institutions, ensuring seamless connectivity across the pharmaceutical industry service network. This will facilitate the translation and commercialization of R&D achievements in innovative drugs and medical devices in Beijing, accelerating the market launch of innovative products.

In accordance with the requirements of the National Medical Products Administration (NMPA) and the Beijing Municipal Committee and Municipal People’s Government, the Beijing-Tianjin-Hebei Sub-center commenced operations on September 21, the day of its unveiling, actively providing consulting services to enterprises in Beijing and bolstering their confidence in deepening their presence in the Beijing market. Xu Zhenyu, Director of the Beijing-Tianjin-Hebei Sub-center, stated that the sub-center would initially launch consulting activities for pharmaceutical and medical device companies in Beijing. It will establish a coordination mechanism with the Beijing Medical Products Administration, fully leverage innovation service stations at all levels in Beijing to collect and address enterprise inquiries, and capitalize on its geographical advantages to strengthen ties with the NMPA’s “Three Major Centers.” By inviting senior review and inspection experts from these centers to provide guidance at the sub-center, it aims to enhance the quality and efficiency of its services to enterprises.

Companies consulted on-site believe that the establishment of the sub-center brings services right to their “doorstep,” offering the unique advantage of “zero-distance” communication with experts. They can engage in in-depth discussions with sub-center specialists at any time regarding technical challenges in early-stage R&D and detailed design of clinical trial protocols. This enables them to gain a clearer understanding of policy and technical requirements, mitigate potential risks during the R&D process, fully empower and accelerate new product launches, and significantly bolster their confidence and determination to sustain investment in new drug development.

Beijing is the source of innovation in the pharmaceutical industry, boasting over 300 national-level innovation platforms, including the highest number of national research institutes and state key laboratories in the field of medicine and health across China, accounting for approximately one-third of the national total. It is home to 126 academicians from the Chinese Academy of Sciences and the Chinese Academy of Engineering in the life sciences sector, representing nearly half of the country’s total. In terms of clinical resources, Beijing leads the nation with 130 tertiary hospitals. It accounts for half of China’s National Clinical Medical Research Centers and national-level key clinical research projects. Approximately 40% of the country’s annual research achievements in the life sciences originate from Beijing.

Beijing attaches great importance to the development of the pharmaceutical industry, having released 32 measures for two consecutive years to promote high-quality development of innovative medicines. It is steadily advancing the construction of the International Pharmaceutical Innovation Park (BioPark) and pharmaceutical industrial parks, attracting globally renowned pharmaceutical companies to establish new innovation entities in Beijing. As a result, Beijing has become the first city in China where the scale of the pharmaceutical and health industry exceeds one trillion yuan.

The Beijing-Tianjin-Hebei Sub-center will fully leverage its inherent advantages in the concentration of pharmaceutical resources in the capital, the policy benefits of pioneering initiatives under the “Two Zones” development framework, and the institutional strengths of coordinated mechanisms among medical care, health insurance, and pharmaceutical services. It will deeply integrate with service mechanisms such as the key project management system for innovative products in Beijing, providing end-to-end support in clinical trials and industrial implementation. Relevant functional departments of the Beijing Municipal Government will also actively support and participate in the operational mechanisms of the Sub-center. They will deepen the implementation of the mechanism featuring “early intervention, tailored strategies for each enterprise, full-process guidance, and integrated research and review” for key products, guide and assist Beijing-based pharmaceutical and medical device enterprises in precisely articulating their needs, coordinate with the Sub-center to deliver efficient enterprise services, and effectively enhance the quality and efficiency of drug and medical device evaluation and inspection in Beijing.

Xu Zhenyu stated that the sub-center will actively investigate the characteristics of Beijing’s pharmaceutical industry development, strengthen training and guidance for enterprises in line with industrial needs, establish and improve face-to-face consultation procedures, proactively provide pre- and mid-stage consulting services, engage in thorough communication with enterprises, and help them enhance the quality of their R&D submissions. Gao Fei, Director of the Medical Device Registration Division of the Beijing Medical Products Administration, noted that the establishment of the sub-center will, on one hand, offer professional guidance—for instance, enabling review experts to intervene earlier in key frontier areas such as artificial intelligence within the region, thereby providing more targeted preliminary coaching to enterprises. This “tailor-made” service can effectively improve the quality of submission materials, optimize the allocation of review resources, and help Beijing’s reviewers enhance their professional capabilities. Meanwhile, it will facilitate more effective coordination of R&D, manufacturing, and clinical resources across the Beijing-Tianjin-Hebei-Shandong region, guiding product development to better align with clinical realities and regional health needs during the preliminary service stage, thus promoting deep integration between the innovation chain and the industrial chain.

Looking ahead, Beijing will strengthen strategic cooperation with the National Medical Products Administration (NMPA) to establish a sound, scientific, efficient, and professional regional system for the review and inspection of drugs and medical devices. The Beijing-Tianjin-Hebei Branch Center will be developed into a practical platform for promoting high-quality integrated regional development, a collaborative platform for deepening reforms in the drug and medical device review and approval systems, and an incubation platform for serving the innovative development of the pharmaceutical industry. It aims to forge a new benchmark for regional drug and medical device review and inspection, characterized by leadership in regulatory science, efficient innovation translation, resilient safety governance, and close regional coordination. By cultivating an innovation ecosystem with global competitiveness, it will gather “new momentum” for regulation, stimulate “new vitality” for innovation, and inject “new strength” into accelerating China’s transition from a major pharmaceutical country to a powerful pharmaceutical nation.

A representative of the Beijing Municipal Medical Products Administration stated that the administration will strengthen communication and coordination with relevant municipal departments and local governments, pool efforts, implement safeguard responsibilities in detail, and make every effort to ensure the efficient operation of the Beijing-Tianjin-Hebei Sub-Center.