Second Boao International Real-World Evidence Symposium: Advancing Collaborative RWD Research for Global Regulatory Innovation

With the rapid development of “new infrastructure” technologies such as artificial intelligence, 5G, blockchain, and the Internet of Things, the healthcare industry is accelerating its digital transformation, and the decision-making models for drug and medical device regulation are undergoing innovation. Technological advancements are enhancing the accessibility and usability of real-world data (RWD). Currently, leveraging RWD for lifecycle regulatory processes, including the review and approval of drugs and medical devices, has become a focal point of attention and exploration for regulatory agencies and relevant international organizations worldwide.

On October 31, the 2nd Boao International Conference on Real-World Studies of Pharmaceuticals and Medical Devices was held as scheduled. Hosted by the People's Government of Hainan Province, the conference centered on the theme “International Real-World Data Research and the Scientific Development of Pharmaceutical and Medical Device Regulation.” It brought together experts, scholars, and distinguished representatives from domestic and international drug regulatory authorities, research institutions, academic societies and associations, and pharmaceutical and medical device companies, all actively engaged in real-world study-related fields.

A thousand guests from government, industry, academia, research institutions, and healthcare sectors both in China and abroad gathered together, aiming to jointly build an exchange platform for real-world data research and innovation in drug and medical device regulation, thereby promoting the scientific development of real-world data research and drug and medical device regulation in China and even globally.

 Shen Danyang, Deputy Secretary of the CPC Hainan Provincial Committee

Shen Danyang, Deputy Secretary of the Hainan Provincial Committee of the Communist Party of ChinaDelivering a welcome address to the conference, he pointed out that the Boao Lecheng International Medical Tourism Pilot Zone is China’s first region to pilot the application of real-world data (RWD), as well as a key industrial park and major functional platform in the construction of the Hainan Free Trade Port. Currently, the Lecheng Pilot Zone has established in-depth cooperative relationships with more than 170 pharmaceutical and medical device companies from 20 countries and regions, and 13 products have been registered and launched in China by leveraging Lecheng’s real-world data to support clinical evaluation.

He stated that this conference serves not only as an intellectual feast for global exchange on real-world data (RWD) research in pharmaceuticals and medical devices, but also as a significant opportunity for Hainan to engage in in-depth discussions on Free Trade Port cooperation with both old and new friends. He expressed the hope that attending experts, scholars, and guests would engage in profound discussions and exchanges here, sparking new ideas, invigorating new vitality, exploring new issues, and jointly planning new development. The goal is to provide new methods, standards, and pathways for leveraging RWD research in regulatory decision-making within the pharmaceutical and medical device sectors in China and globally, thereby positioning the Boao Lecheng International Medical Tourism Pilot Zone as a highland for regulatory innovation, pharmaceutical innovation, and talent aggregation, and propelling real-world study to become a new engine for the development of China’s pharmaceutical industry.

Jiao Hong, Standing Committee Member of the National Committee of the Chinese People's Political Consultative Conference and Vice Chairperson of the Central Committee of the Chinese Peasants and Workers Democratic Party

Jiao Hong, Standing Committee Member of the National Committee of the Chinese People's Political Consultative Conference (CPPCC), and Vice Chairperson of the Central Committee of the Chinese Peasants and Workers Democratic PartyThe address stated that the health of the people is a significant indicator of national prosperity and strength. The development of the Boao Lecheng International Medical Tourism Pilot Zone is not only a crucial task in comprehensively deepening reform and opening-up, but also an important lever for building an international tourism and consumption center. It bears the significant responsibility of promoting the development of Hainan’s health industry, enabling Chinese citizens to access more advanced pharmaceuticals, medical devices, and medical technologies, and thereby advancing healthcare system reforms. Under the strong leadership of the Hainan Provincial Committee of the Communist Party of China and the Provincial People’s Government, and with robust support from national ministries and commissions such as the National Medical Products Administration, the Lecheng Pilot Zone has become a fertile ground for medical reform, featuring a series of special policies including特许医疗 (special medical services), 特许经营 (special franchising), 特许国际医疗交流 (special international medical exchanges), and 特许研究 (special research). Through integrated institutional innovation, it has pioneered a path for medical reform and innovation in China, continuously enhancing the radiating influence and competitiveness of the medical and health industry, and establishing itself as a new highland for innovative development in China’s medical and health sector. Moving forward, the Central Committee of the Chinese Peasants and Workers Democratic Party will continue to pay close attention to the development of the Lecheng Pilot Zone, leverage its intellectual advantages within its primary constituencies, mobilize party member experts in fields such as medicine, public health, and ecological environment, actively support the construction of the Lecheng Pilot Zone, and contribute to forming a new pattern of higher-level reform and opening-up.

Xu Jinghe, Deputy Director of the National Medical Products Administration

Xu Jinghe, Member of the Party Leadership Group and Deputy Director of the National Medical Products AdministrationIt was stated that the National Medical Products Administration (NMPA) has earnestly implemented the major decisions and deployments of the Central Committee of the Communist Party of China and the State Council. In 2019, in collaboration with the Hainan Provincial People's Government, the NMPA provided high-level impetus to the pilot program for real-world data (RWD) research on pharmaceuticals and medical devices in Boao. Over the past four years, significant phased achievements have been made in accelerating the market approval process for innovative pharmaceuticals and medical devices, improving the regulatory framework for RWD applications, establishing a base for RWD research on pharmaceuticals and medical devices, and building cooperative exchange platforms for real-world studies. Through the RWD pilot program in Hainan, the NMPA has approved the marketing of four pharmaceutical products and nine medical devices. These efforts have not only met clinical needs and benefited public health but also accumulated valuable experience in applying RWD to regulatory decision-making. Moving forward, the NMPA will continue to work with Hainan Province to advance the RWD application pilot program, promote the use of RWD to support the market launch of innovative pharmaceuticals and medical devices, lead innovative RWD research in the sector, and foster consultation, joint development, and sharing in RWD research.

Hainan Provincial People's Government Vice Governor Xie Jing presided over the opening ceremony

Martin Taylor, WHO Representative in China

Martin Taylor, WHO Representative to ChinaIn his online address, he stated that China has not only made progress in improving drug quality and stimulating innovation but has also begun to take measures to incorporate real-world data and evidence into regulatory policies and medical practices. The World Health Organization supports its member states in leveraging innovative and digital interventions to strengthen healthcare systems, expand healthcare coverage, and generate more timely and reliable data. China can play a significant role in fully utilizing data and technology while managing risks, advancing the development of regulatory systems, and better improving public health based on evidence.

Academician Luo Qingming, Member of the Chinese Academy of Sciences, President of Hainan University, and Honorary Dean of Hainan Zhenyan Institute

Next,Academician Luo Qingming, Member of the Chinese Academy of Sciences, President of Hainan University, and Honorary Dean of Hainan Institute for Advanced StudyHe delivered a speech themed on “Achievements of the Pilot Program for Real-World Data Application in Boao Lecheng, Hainan.” He pointed out that to strengthen the training and reserve of talent in real-world research, the Hainan Institute for Real-World Data Research has collaborated with Hainan University to establish China’s first interdisciplinary joint master’s and doctoral training program in real-world data application. The program has completed admissions for the three academic years from 2021 to 2023, enrolling 24 master’s students and 15 doctoral students. “Under the guidance of the National Medical Products Administration and with the support of the Ministry of Education, we aim to explore the establishment of an interdisciplinary field in regulatory science. Relevant feasibility studies are currently underway,” stated Academician Luo Qingming.

Following the opening ceremony, the event proceeded to the keynote speech session. This session was moderated by Professor Qu Jia, Chairman of the Hainan Institute for Real-World Data and Director of the Department of Ophthalmology and Optometry at Wenzhou Medical University. During this session, five experts and scholars from regulatory agencies both in China and abroad delivered insightful presentations on the theme.

Yang Zhimin, Deputy Director of the Center for Drug Evaluation, National Medical Products Administration

First,Yang Zhimin, Deputy Director of the Center for Drug Evaluation, National Medical Products AdministrationSharing on the theme of “Chinese Practices in Applying Real-World Evidence to Drug Evaluation.” Yang Zhimin pointed out that in recent years, the Center for Drug Evaluation (hereinafter referred to as the “CDE”) under the National Medical Products Administration has organized the development of a series of guidelines. These guidelines provide active guidance and standardization on overall study design, data quality assessment, and communication for real-world studies, as well as on key issues requiring special attention in priority areas such as pediatric drugs, drugs for rare diseases, and traditional Chinese medicine. These efforts have promoted exploration in these key application areas and facilitated the deepening of real-world study practices.

Sun Lei, Director of the Center for Medical Device Technical Evaluation, National Medical Products Administration

Sun Lei, Director of the Center for Medical Device Technical Evaluation, National Medical Products AdministrationIn the keynote speech titled “Research and Practical Advances in Real-World Evidence Supporting the Evaluation of Medical Devices,” it was pointed out that the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (hereinafter referred to as the “CMDE”) has been continuously advancing the use of real-world evidence for product registration. To date, two batches comprising 13 varieties have been included in the pilot program for the application of real-world data in medical devices, among which 9 products across 7 varieties have received marketing approval. As more pilot varieties gain marketing approval, the CMDE is exploring the institutionalization of routine applications of real-world data for medical devices.

Regarding the next steps, Sun Lei stated that, within the framework of building Version 2.0 of the modernized review system, the Center for Medical Device Evaluation will actively advance the research and utilization of real-world data, further enhancing the role of real-world evidence in the evaluation of medical devices, particularly high-risk products and new products.

Shen Chuanyong, Director of the Center for Drug Evaluation, National Medical Products Administration

Next,Shen Chuanyong, Director of the Center for Drug Evaluation, National Medical Products AdministrationDelivered a keynote speech on “Exploring the Use of Real-World Data/Evidence for Post-Market Safety Monitoring of Drugs and Medical Devices.” Shen Chuanyong pointed out that China has initially established a national pharmacovigilance system, with the Center for Drug Reevaluation of the National Medical Products Administration (National Center for Adverse Drug Reaction Monitoring) as the core; supported by institutions such as the Institute of Pharmacovigilance at Nanjing Medical University, the Innovation Center for Pharmacovigilance Information Technology and Data Science, and the NMPA Key Laboratory of Pharmacovigilance Research and Evaluation; supplemented by provincial adverse drug reaction monitoring centers; and anchored by nodes including 36 sentinel hospitals for adverse drug reaction monitoring and 105 sentinel hospitals for adverse medical device event monitoring across the country.

Shen Chuanyong stated that actively promoting the application of real-world data/real-world evidence (RWD/RWE) in pharmacovigilance and medical device vigilance helps to continuously enhance China’s capabilities in identifying and evaluating risks associated with pharmaceuticals and medical devices, thereby reinforcing the primary responsibility of enterprises for quality and safety.

John Concato, Deputy Director of the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Next, the conference screenedJohn Concato, Deputy Director of the Office of Medical Policy at the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)Keynote Video on “Progress in the U.S. Food and Drug Administration’s Work on Real-World Evidence.” He reviewed the FDA’s efforts in real-world evidence (RWE), analyzed the current state of real-world research, introduced recently issued FDA guidance documents and pilot programs, and raised three representative questions regarding RWE: first, the sources of RWE; second, the design of non-randomized studies; and third, the conduct of non-randomized studies.

Christopher LAM, Head of the Medical Device Quality Systems, Adverse Events and Compliance Division at the Health Sciences Authority (HSA) of Singapore

At the conclusion of the conference,Christopher LAM, Head of the Medical Device Quality System, Adverse Events and Compliance Division, Health Sciences Authority (HSA) of SingaporeDelivered a keynote speech titled “The Use of Real-World Evidence in Medical Device Regulation: HSA’s Perspective.” He pointed out that, in the realm of medical device regulation, the Health Sciences Authority (HSA) has established a regulatory framework covering the entire lifecycle of medical devices, encompassing oversight of distributor qualifications, product registration, and post-market surveillance. Real-world data can serve as critical information for the registration evaluation of Class B, C, and D medical devices (medium-to-high risk) in Singapore, supporting HSA’s decision-making. The real-world evidence derived from such data can enrich the clinical evidence regarding the safety and efficacy of medical devices.

At the conclusion of his presentation, Christopher Lam stated that practice has demonstrated the positive role of real-world data (RWD) in evaluating specific functions of medical devices. However, it is important to note that relying solely on RWD is insufficient for the evaluation of medical devices; such data should be analyzed in conjunction with other clinical data or studies to mitigate the impact of potential gaps in RWD on clinical evaluations.

In addition to the plenary sessions, the conference featured eight specialized forums covering Real-World Data Research and Drug Regulation, Medical Device Regulation, Traditional Chinese Medicine Regulation, Post-Marketing Safety Evaluation of Drugs and Medical Devices, Specialized Disciplines and Diseases, Biostatistics, Information Technology, and Health Economics. Industry experts further discussed the current status, achievements, and future trends of real-world research from these specialized perspectives.

In 2019, the Hainan Provincial People's Government and the National Medical Products Administration (NMPA) jointly launched a pilot program for the application of real-world data (RWD) in clinical settings within the Boao Lecheng International Medical Tourism Pilot Zone, providing new pathways and methodologies for reforming China’s drug and medical device review and approval system. To strengthen the global aggregation of real-world study resources and promote exchanges among government, industry, academia, research institutions, and end-users, the Hainan Provincial People's Government has designated Boao, Hainan as the permanent venue for the annual "Boao International Conference on Real-World Studies of Pharmaceuticals and Medical Devices."

Since the launch of the pilot program for the application of real-world data (RWD) in clinical evaluations within the Boao Lecheng International Medical Tourism Pilot Zone, nine medical devices and four pharmaceutical products have received registration approval from the National Medical Products Administration (NMPA) by leveraging Lecheng’s real-world data to support clinical assessments, thereby accelerating their market entry in China. This pilot program has laid a solid practical foundation for the NMPA to incorporate real-world data into regulatory decision-making for the clinical evaluation of drugs and medical devices, as well as for formulating relevant guidelines, regulations, and standards. It has contributed “Lecheng wisdom” and “Hainan strength” to the reform of China’s drug and medical device review and approval system, facilitating the faster registration and approval of innovative foreign medical products in China.

By 2025, the Boao Lecheng International Medical Tourism Pilot Zone will achieve breakthrough progress in establishing advanced clinical medical centers with specialized expertise and bases for the research, development, and translation of cutting-edge medical technologies, thereby realizing “triple synchronization” of medical technologies, equipment, and pharmaceuticals with international advanced standards. By 2030, its medical services and scientific research will reach a leading position domestically and an advanced level internationally, fully forming industrial agglomeration and brand effects, and establishing itself as a world-class international medical tourism destination and a platform for medical technology innovation.

The role of real-world studies in pharmaceutical and medical device research and development regulatory policies is increasingly recognized, providing new pathways and methodologies for China’s drug and device regulation and holding significant value in promoting the generation and translation of innovative outcomes. As the first region in China to launch pilot programs on the application of clinical real-world data, the Boao Lecheng International Medical Tourism Pilot Zone has established a channel to accelerate the entry of international innovative drugs and medical devices into the Chinese market, carrying profound implications for reforms in drug and device registration and regulation.