NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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A delegation led by Jiao Hong, director of NMPA, visit Lecheng Pilot Zone to inspect the implementation of licensed medical product policies and real-world data applications

2023-02-17 811

On February 16, Jiao Hong, director of the National Medical Products Administration (NMPA) inspects the implementation of urgently needed imported medical products (licensed medical products) and real-world data applications in the Lecheng International Medical Tourism Pilot Zone in Boao of Hainan. Jiao emphasized that we should put the people and lives at the first position, make a full use of the major development opportunities in the construction of the Hainan Free Trade Port and the promotion of Healthy China strategy, constantly deepen the reform of medical products review and approval system, innovate the supervisory measures for licensed medical products, carry out the strictest regulation and supervision, fulfill the responsibilities of subjects such as medical institutions and enterprises, so as to ensure that good policies can truly benefit the people and boost the high-quality development of the medical industry in Hainan. Gu Gang, the vice governor of the government of Hainan province, participated in related inspection and survey activities.

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The delegation visited the Lecheng International Innovation Medical Products Exchange Center, Ruijin Hainan Hospital, Lecheng Medical Products Administration in succession and conducted a field inspection on the issues and conditions such as the implementation of licensed medical products policies, the management of licensed medical product uses, the construction of the real-world database and platform, the real-world studies. During their visit, they inspected the progress of the West China Hospital Lecheng and held a forum to have an in-depth exchange of views with the Hainan Medical Products Administration, the Lecheng Medical Products Administration and experts of related professional research institutes and medical institutions. Gu Gang attended the discussion and delivered a speech on behalf of the provincial government. In the forum, Jia Ning, the CPC secretary and director of Lecheng Pilot Zone Administration, reported the construction and development status of Lecheng Pilot Zone and the real-world data applications. The meeting was presided over by Zhang Huawei, the deputy secretary general of the government of Hainan Province.

As pointed out by Jiao Hong, first, we should strengthen the fulfillment of responsibilities and make a good use of the licensed medical product policies. We should accelerate the revision of regulations on urgently needed medical products and enhance the regulatory quality and efficiency of licensed medical products. We should strengthen the whole-process management of licensed medical products, perform the regulatory and supervisory responsibility strictly to ensure that all medical institutions fulfill their subjective responsibility and spare no effort to guarantee the safety of medical product usage. Second, we should solidify the foundation and continually improve the quality of real-world studies. The strength of each concerned party should be coordinated to promote the regulation and scientific research of real-world data continually and form new high-level tools, standards and methods so as to provide new approaches and channels for reforming the national medical products review and approval system, promoting the research and development of innovative medical products in China and facilitating the availability of global innovative products in clinical applications in China. The real-world study platform should be built and utilized well to pool the resources of different parties, build the Boao International Conference on Real-world Studies of Medical Products into an international exchange and cooperation platform with a global influence and appeal. Third, we should accelerate the commercialization of research fruits and boost the high-quality development of the medical industry. The construction of high-level research-based hospitals should be promoted according to the world-class standards, and high-level clinical tests should be organized to promote the commercialization of research fruits of innovative medical products. No effort should be spared in strengthening the construction of the regulatory capacity to fully enhance the capacity of the regulatory system in such issues as review, inspection, test, monitoring and evaluation and further solidify the foundation for monitoring and boosting the high-quality development of the industry.

The forum was attended by staff and personnel of related departments and immediate subordinates of the NMPA, the Office of Hainan Provincial Government and related departments.