Hainan Boao Lecheng International Medical Tourism Pilot Zone (referred to as Lecheng Pilot Zone), as the only "medical special zone" in the country and one of the key parks for the construction of Hainan Free Trade Port, has always been an experimental field for bold experiments, bold attempts and independent reforms. Lecheng continuously deepens and promotes system integration innovation, and is even more daring and responsible in the pilot work of real-world data application, and actively promotes the implementation of more forward-looking results, so that more international innovative medical devices can benefit more Chinese people.

Since the launch of the pilot work of clinical real-world data application, under the leadership and vigorous promotion of the State Food and Drug Administration and the Hainan Provincial Government, the pilot work in the Lecheng Pilot Zone has been carried out in an orderly manner. Attracted by the dividends of the pilot policy, major multinational pharmaceutical and device companies around the world have come to Lecheng for cooperation. Up to now, more than 60 pharmaceutical equipment companies have cooperated with Lecheng. Looking back on the whole year of 2020, what representative work has Lecheng done in promoting the pilot application of real-world data? And how did you dare to try and actively promote the further implementation of relevant work? Let's take a look together!

2020 Annual Inventory

01

On the morning of December 28, 2020, the Hainan Provincial Food and Drug Administration, together with the Lecheng Pilot Area Administration, held a kick-off meeting for the pilot varieties of clinical real-world data application of drugs and medical devices in Beijing. Representatives of relevant departments and bureaus and directly affiliated units of the State Food and Drug Administration attended the meeting .

The meeting read out the approval documents for the pilot launch of the first batch of drugs and the second batch of medical devices. This time, the launch of the first batch of 3 drugs and the second batch of 11 medical device pilot varieties has further expanded the scope and scale of the pilot varieties, providing "Hainan experience" for deepening the reform and innovation of the national drug and medical device review and approval system, contributing to "Hainan Wisdom" to better serve the needs of the people to accelerate the use of global innovative pharmaceutical products.

 

02

On December 28, 2020, after the kick-off meeting, a group meeting of pilot varieties of real-world data application for drugs and medical devices was held simultaneously. Relevant leaders, experts, representatives of medical institutions and representatives of pilot varieties enterprises conducted face-to-face communication and exchanges with relevant departments and bureaus of the State Food and Drug Administration and directly affiliated units. The pilot enterprise reported the clinical program design, medical team planning and next-step work plan. The review agency put forward specific work requirements for the review of the real-world data application pilot varieties, and the two parties conducted in-depth discussions and exchanges.

 

 

03

On the afternoon of December 28, 2020, the Hainan Real World Data Research Institute held a consultation meeting on the construction of a real world data platform in Beijing. The meeting invited the Drug Evaluation Center of the State Food and Drug Administration, the Information Center of the State Food and Drug Administration, the Food and Drug Review and Inspection Center of the State Food and Drug Administration, the Drug Evaluation Center of the State Food and Drug Administration, the Hainan Provincial Food and Drug Administration, the Hainan Provincial Big Data Bureau, Relevant leaders and business leaders of the city management bureau, president of Hainan Real World Data Research Institute and member of the academic committee, project experts of various scientific research universities, medical institutions, and industry associations, business leaders of medical institutions, pharmaceutical equipment companies, and CRO companies in Lecheng Park , Nearly 70 people from relevant teams of information technology companies attended the meeting, and conducted in-depth opinions and exchanges on the needs and ideas of real-world data platform construction.

 

 

04

On the morning of December 27, 2020, the Hainan Provincial Food and Drug Administration and the Lecheng Administration jointly held a symposium on the scientific research base of drug and medical device supervision of the State Drug Administration in Beijing to accelerate the construction of regulatory science bases and real-world data research. Work.

Xu Jinghe, deputy director of the State Drug Administration and leader of the pilot work of clinical real-world data application in Boao Lecheng, Hainan, attended the meeting and delivered an important speech. The Science and Technology and International Cooperation Department of the State Food and Drug Administration, the Drug Registration Department of the State Food and Drug Administration, the Device Registration Department of the State Food and Drug Administration, the Device Evaluation Center of the State Food and Drug Administration, the Central Inspection Institute, the Hainan Provincial Food and Drug Administration, and the Lecheng Administration are responsible for People, leaders of Hainan Real World Data Research Institute and relevant industry representatives, highly integrated from all walks of life, government, industry, academia and clinical use, focusing on how to make full use of the relevant policies of Hainan Free Trade Port and Lecheng to promote clinically urgently needed imports on the platform of the regulatory science base The discussion on the safety supervision of innovative pharmaceutical devices and real-world data research will provide suggestions for the scientific development of drug supervision in my country.

 

 

05

On the afternoon of December 27, 2020, the first working meeting of the director of the Hainan Real World Data Research Institute was held in Beijing. The meeting discussed and deployed the operating mechanism, management model and work plan of the institute. The leaders and experts of the participating institutes unanimously expressed that they will use pioneering and innovative ideas, unified and efficient actions, and work together to build the main position of the Hainan Real World Data Research Institute, and to deepen and solidify clinical real world data research to help regulatory science. Development and innovation contribute to "Hainan Wisdom".

 

 

06

On November 27, 2020, Hainan Real World Data Research Institute was officially listed and was awarded the "Scientific Research Base for Drug and Medical Device Supervision of the State Drug Administration". The leaders of the State Drug Administration and the relevant leaders of the Hainan Provincial Government are the research bases. Unveiling. Academician Luo Qingming serves as the honorary president of the institute. The establishment of the research base and research institute marks that Lecheng's real-world data research is moving towards a higher starting point and platform.

07
On November 27, 2020, the State Food and Drug Administration and the Hainan Provincial Government held a work symposium and the second (expanded) meeting of the leading group of clinical real-world data application pilot work in Boao, Hainan Province to jointly discuss the promotion of Hainan Free Trade Port Pharmaceutical Equipment Regulatory innovation and high-quality development plans. Shen Xiaoming, Secretary of Hainan Provincial Party Committee (then Governor), Jiao Hong, Director of the State Food and Drug Administration, and Shen Danyang, Vice Governor of Hainan Province, attended the meeting. Deputy Director of the State Food and Drug Administration, Hainan Boao Lecheng Clinical Real World Data Application Pilot Work Leader Group leader Xu Jinghe presided over the meeting.  

The meeting pointed out that the construction of a free trade port in Hainan is a major reform and opening-up initiative personally planned, deployed and promoted by General Secretary Xi Jinping. It is of great significance to reform the review and approval system for drugs and medical devices and to better meet the needs of the people for using high-level medical devices. Carrying out the clinical real-world data application pilot in Hainan is an important part of the SFDA's drug regulatory scientific action plan, actively promoting the formulation of data collection plans and guiding principles for drugs and medical devices, determining the review and approval path for the pilot varieties, and has Some pilot varieties have been approved for marketing using clinical real-world evidence for the first time, providing valuable experience for innovative drug and medical device supervision models.

 

 

08

On November 6, 2020, the Hainan Provincial Food and Drug Administration and the Lecheng Administration jointly held a consultation meeting on the construction of the Lecheng real-world data research platform in Beijing. The State Food and Drug Administration Information Center, Drug Evaluation Center, and Medical Device Evaluation Center Relevant persons in charge and review experts attended the meeting and put forward professional suggestions and opinions on the platform construction.

 

 

09

On October 30, 2020, a video conference was held on the construction ideas of the Boao Lecheng real-world data research platform, led by the Hainan Provincial Food and Drug Administration and in collaboration with the Lecheng Administration. The meeting was presided over by Li Zhiping, the main person in charge of the Hainan Provincial Food and Drug Administration, Deputy Director Zhu Ning, Deputy Director Li Yunda, and the heads of relevant departments such as the Provincial Drug and Equipment Review Service Center, Deputy Director Fu Zhu of the Lecheng Administration and related personnel attended the meeting and conducted the meeting. During the discussion, Sun Xin, Yao Chen, Chen Feng and other evidence-based medicine experts participated remotely and put forward their opinions and suggestions.

 

 

10

On October 23, 2020, a pilot symposium on the application of real-world data in drug clinical trials was held in Lecheng. The meeting was jointly organized by the Drug Evaluation Center of the State Food and Drug Administration, the Drug Registration Department of the State Food and Drug Administration, the Hainan Provincial Food and Drug Administration and the Lecheng Administration. hold. Director Kong Fanpu, Deputy Director Zhou Siyuan of the Drug Evaluation Center of the State Food and Drug Administration, relevant persons in charge of the Drug Registration Department of the State Food and Drug Administration, the Hainan Provincial Food and Drug Administration, the Lecheng Administration Bureau, and experts in the field of evidence-based medicine attended the meeting and discussed the pharmaceutical and equipment enterprises. Answers to the questions raised by the representatives on the research and application of clinical real-world data.

 

 

11

On October 22, 2020, the Hainan Provincial Food and Drug Administration held an expert review meeting for the second batch of pilot varieties of clinical real-world data application for medical devices in Haikou. The relevant persons in charge of the Device Registration Department of the State Food and Drug Administration, the director of the Device Review Center, senior reviewers and experts from medical institutions, and the relevant persons in charge of the Hainan Provincial Food and Drug Administration, the Hainan Provincial Health Commission, and the Lecheng Administration participated. Comments and suggestions on the research plan of the second batch of real-world research pilot varieties of devices.

 

 

 

12

On October 14, 2020, the Lecheng Administration organized a seminar on the construction of a real-world data research platform. Hainan Provincial Food and Drug Administration, the relevant personnel of the Provincial Big Data Bureau, experts in evidence-based medicine, clinical, big data, as well as the heads of medical institutions in the park and information management personnel are forward-looking, scientific, rational, and In-depth discussion on operability and other aspects. All parties in the conference worked together to discuss the feasible path for the construction of the Lecheng real-world data platform, hoping to form a feasibility study plan as soon as possible to promote the pilot work of the clinical real-world data application of Lecheng.

 

 

13

From September 25th to 26th, 2020, the "3rd National Conference on Real World Data and Research" jointly organized by West China Hospital of Sichuan University, Hainan Provincial Food and Drug Administration, Lecheng Administration, China Evidence-Based Medicine Center and other units Lecheng was held. Academician Zhang Xingdong of Sichuan University and Gao Guobiao, Secretary of the Party Committee of the Device Review Center of the State Food and Drug Administration, made a keynote report, and experts from the Drug Evaluation Center and Device Evaluation Center of the State Food and Drug Administration made a special report. West China Hospital, Hainan Provincial Food and Drug Administration, Lecheng Administration and other leaders, experts in related fields and business representatives attended the meeting to discuss and communicate on the theme of "Real World Evidence Supports Decision-Making of Drug Device Supervision-China Practice". The conference invited Professor Sun Xin as the director of the "Boao Lecheng Real World Data Research and Innovation Center", and held the establishment ceremony of the "Boao Lecheng Eye Disease Real Data Platform" simultaneously.

 

 

14

From September 3rd to 4th, 2020, the 2020 Real World Data and Evidence Research Exchange Conference was held in Boao Lecheng. This conference was hosted by the China Food International Exchange Center and co-organized by the Hainan Provincial Food and Drug Administration and the Lecheng Administration. Zhang Qi, Deputy Director of the Medical Device Supervision Department of the State Food and Drug Administration, attended the meeting. Gao Guobiao, Secretary of the Party Committee of the Device Review Center of the State Food and Drug Administration, and experts from academia and industry at home and abroad made keynote reports on the research and practice of real-world data and evidence. Application for in-depth discussion and communication.

 

 

15

On August 18, 2020, Boao Research Hospital (preliminary operation) and Lecheng District of Hainan Provincial People's Hospital were officially put into operation in Lecheng, Boao. Leaders from Hainan Provincial Health Commission, Provincial Food and Drug Administration, and Lecheng Administration attended the ceremony. Listing ceremony. Through the promotion of the Boao Lecheng clinical real-world data application pilot, the research-oriented hospital will gradually satisfy the needs of about 800,000 domestic patients who choose foreign medicines and instruments for treatment.

 

 

16

On July 10, 2020, the Academic Exchange Training Conference on Real World Data Research was held in Boao Lecheng. The training meeting attracted more than 200 domestic and foreign manufacturers to participate online and offline, and many service platforms such as CROs and investment institutions actively participated in the meeting. The holding of the academic exchange training meeting on real-world data research has deepened the understanding of the overall work of real-world data by pharmaceutical and device companies, and is conducive to related companies to optimize the design of research programs for pilot varieties of real-world data applications, and promote the efficiency of product declaration and review.

 

 

17

In order to thoroughly implement the spirit of General Secretary Xi Jinping's important speech at the celebration of the 30th anniversary of Hainan's establishment of a special economic zone, and to further meet the use and supervision needs of patients who urgently need imported medical devices in Lecheng, the Hainan Provincial Food and Drug Administration combines practical work and Lecheng's development. As well as the pilot situation of clinical real-world data application, the "Interim Regulations on the Administration of Imported Medical Devices Urgently Needed for Clinical Practice in the Hainan Boao Lecheng International Medical Tourism Pilot Area" (Qiong Fu [2018] No. 30) has been revised, focusing on revisions that do not meet the needs of current development. Provisions, appropriately adjust, improve and enrich the content that is compatible with the development of Lecheng, and further enhance the pertinence and operability of the regulations. In June 2020, the provincial government issued the revised "Regulations on the Administration of Imported Medical Devices Urgently Needed for Clinical Practice in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone" (Qiong Fu [2020] No. 28).

 

 

18

On April 10, 2020, the Boao Lecheng Real World Data Research and Innovation Center was inaugurated, which further provided a strong guarantee for the implementation of the Lecheng policy. Boao Lecheng Real World Data Research and Innovation Center is a non-governmental organization jointly established by West China Hospital of Sichuan University, Hainan Provincial Drug Administration and Lecheng Administration to carry out basic research on real world data applications of drugs and medical devices. West China Hospital of Sichuan University will continue to formulate relevant technical specifications for real-world evidence research by investing in the talents and equipment of the "Real-World Data Research and Innovation Center" in Boao Lecheng, and serve to improve the level of medical and health decision-making in my country.

 

 

19

On March 26, 2020, the State Food and Drug Administration approved the registration of Allergan's glaucoma drainage tube products. On March 28, the Hainan Provincial Government Information Office held a press conference in Lecheng, announcing that the Lecheng Pioneer Zone had achieved two major institutional and mechanism breakthroughs: first, the first medical device using Lecheng real-world data was approved for registration; The pilot project of real-world data application has achieved preliminary results; secondly, the "Interim Measures for the Administration of the Use of Imported Drugs Urgently Needed for Clinical Use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone" was reviewed and approved, allowing patients to import only for their own use and a small amount of oral drugs that are urgently needed for clinical use. Medicines should be taken away from the advance area for use.

 

 

Epilogue

The launch of the pilot work of clinical real-world data application in Boao Lecheng, Hainan, makes full use of the advantages of the policy system and mechanism of the Lecheng Pilot Zone, which is an extension of the policy of Lecheng's clinical urgently needed imported licensed medicinal devices, and is the review of Chinese medicines and medical devices. One of the important explorations in the reform of the approval system is conducive to promoting the import registration process of international advanced medical devices in China, providing more choices for domestic patients to use medical devices, and promoting the accessibility of medical devices to the public. In 2021, the Lecheng Pioneer Zone will stand at a higher starting point, with a more open attitude, dare to try and take responsibility, and continue to promote the pilot work of real-world data application, so as to reform the review and approval system of Chinese medical devices and accelerate the development of foreign innovative medical device products. Listed in China, serve more Chinese patients, contribute Lecheng wisdom and Hainan power! Lecheng - "City of Hope" for patients, 2020 will be fruitful, and 2021 will go forward