NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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A Learning and Co-building Event Launched with the Theme of “Deeply Implementing New Development Con

2022-04-25 823

On April 24, the Party committee of the Center for Medical Device Evaluation, NMPA (hereinafter referred to as the Center), the Party group of Hainan Medical Products Administration (hereinafter referred to as the HMPA), and the Administration of Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Administration) held an online learning and co-building conference with the theme of “deeply implementing new development concepts and seeking high-quality development of medical device industry together”.

The conference was presided over by Sun Lei, director and deputy Party committee secretary of the Center, in which the attendees studied the guideline of the keynote speech delivered by Xi Jinping, the Secretary General of the CPC Central Committee, in his inspection trip to Hainan in April this year.

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Gu Gang, the Party secretary general and head of the Lecheng Administration, shared his views on the development fruits of the Lecheng Pilot Zone in recent years. In the past four years, under the patient guidance of related ministries and commissions such as the NMPA, the correct leadership of the Hainan Provincial CPC committee and government and support of departments such as the HMPA, the Lecheng Administration has kept in mind the earnest instructions from Secretary General Xi Jinping, insisted on institutional integration and innovation, constantly hastened the unleash of policy bonus and optimized the business environment, and made a series of achievements in such aspects as attracting the back-flow of overseas medical consumption, integration of medical care, teaching and research, and the real-world data research and application piloting. Guided by the guideline of the keynote speech delivered by Secretary General Xi Jinping in his inspection trip to Hainan, the Lecheng Administration has deeply studied and understood and carefully implemented the guideline, bearing in mind the “the top priorities of the country” and “putting the people and their life at the most important position”. With the aid of institutional integration and innovation, it has continuously deepened the reform and innovation, promoted the high-quality development of medical device industry, strengthened risk prevention and control and guarded the bottom line of medical safety, turning Lecheng Pilot Zone from a policy highland to a platform highland and contributing its strength to the construction of a free trade port with Chinese characteristics and global influence. Gu Gang, on behalf of the Lecheng Administration, expressed heartfelt gratitude for the long-term support and help for the development of Lecheng from related immediate organizations such as the Center for Medical Device Evaluation, NMPA and related departments such as HMPA.

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Zhu Ning, Party group secretary and head of HMPA, pointed out that recently the Center for Medical Device Evaluation, NMPA and the HMPA jointly formulated and released the “Communication Procedure on the Pilot Medical Devices for Real-world Data Applications in Lecheng Pilot Zone” and the piloting scale was expanding continually. The first Covid-19 antigen detection reagent of Hainan was approved by the NMPA to be marketed at a faster pace. These important achievements have highlighted the firm resolution of the NMPA and related immediate organizations in implementing the decisions and deployments of the CPC Central Committee and the State Council. They have provided all-out support and patient guidance for Hainan to serve the pandemic prevention and control and deepen the reform and innovation in support of the high-quality development of medical industry and Lecheng Pilot Zone. In the next step, the HMPA will continue to prioritize protecting and serving the people’s health, institutional integration and innovation, safety risk analysis and control under the strong support of the NMPA, continuously deepen and promote the licensed medical product policy in Lecheng Boao, perfect the coordination mechanism for each work in the real-world data application research and piloting and make new contributions for accelerating the construction of a free trade port with Chinese characteristics and global influence.

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In the conference, Yan Zhi, a Party committee member and deputy director of Lecheng Administration, a cadre sent by the Organization Department of CPC Central Committee, Li Yaohua, director of HMPA Center for Drug and Medical Device Evaluation and Service, and Liu Yinghui, director of the Clinical and Biostatistics First Department, NMPA, shared their views based on their respective actual work status.

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Sun Lei, director and deputy Party committee secretary of the Center for Medical Device Evaluation, shared his views and delivered a summary speech based on the medical device review and approval work. He pointed out, in order to accurately grasp the requirements of the new development stage, deeply implement the new development concepts and hasten the establishment of a new development pattern, we should fully implement the guideline of important directions given by Secretary General Xi Jinping on medical product regulation, fully understand the new situation and tasks faced by us in the development of medical device evaluation, further deepen the reform of medical device review and approval system and build a scientific, efficient modernized evaluation system. The Center for Medical Device Evaluation, NMPA will firmly assume its mission and responsibility, strengthen contact with and support for the HMPA and Lecheng Administration to promote the high-quality development of medical device industry and better satisfy the people’s demand for safety, effectiveness and accessibility of medical devices. The event has further promoted the work relationship among the Center for Medical Device Evaluation, HMPA and Lecheng Administration, strengthened their communication and exchange and widened the new ideas of work. Every organization said that they will take the event as an opportunity to promote the innovation of medical device industry, strengthen the work promoting mechanism proposed by Xi Jinping characterized by “central planning, departmental support and implementation by the province”, implement the new development concepts, facilitate the high-quality development of Lecheng and the construction of a free trade port with Chinese characteristics and global influence, and turn Hainan into a model of reform and opening up of China in the new era.

The conference was attended by leaders and cadres of division level and secretary of each Party branch of the Center for Medical Device Evaluation, NMPA, leaders, full-time deputy Party committee secretaries and Party member representatives of some Party branches of HMPA, leaders and all Party members of the Party branch of the Lecheng Administration.