Experts Gather in Boao Lecheng to Advance Real-World Evidence for Innovative Drug and Device Evaluation

In recent years, the global pharmaceutical and medical device sectors have been undergoing profound transformation. With the widespread adoption of information technology in healthcare, including electronic health records (EHRs), electronic medical record (EMR) systems, and hospital information systems (HIS), the digitization of medical data has continuously increased. This has made the collection, storage, and management of data more convenient and efficient, thereby enabling the large-scale collection of patient diagnosis, treatment, and disease management data in real-world settings.

This qualitative transformation, driven by the accumulation of quantitative changes, is propelling Real-World Data (RWD) to the center stage of the healthcare sector. Leveraging its unique advantages—being rooted in real-world clinical settings and reflecting the full spectrum of daily medical practice—RWD is continuously expanding its application landscape and deeply penetrating various segments of the pharmaceutical and medical device industries. From enabling more comprehensive and precise assessments of efficacy and safety during new drug development, to tracking the performance of medical devices in complex post-market use scenarios, RWD has demonstrated significant influence. In light of this, regulatory authorities both in China and abroad have successively issued relevant policies, regulations, and guidelines governing the use of real-world evidence/data for the review and regulation of drugs and medical devices.

On November 23, the 3rd Boao International Conference on Real-World Studies of Pharmaceuticals and Medical Devices was held in Boao, Hainan. Centered on the theme “Real-World Studies Facilitating Clinical Evaluation of Innovative Pharmaceuticals and Medical Devices,” the conference attracted numerous experts, scholars, regulatory officials, and corporate representatives. Attendees shared the latest concepts in regulatory science for pharmaceuticals and medical devices, showcased advanced scientific research achievements, and jointly promoted the development of global health initiatives.

Gu Gang, Vice Governor of the People’s Government of Hainan Province, and Xu Jinghe, Deputy Commissioner of the National Medical Products Administration, attended the plenary session and delivered speeches. Ning Guang, Academician of the Chinese Academy of Engineering and President of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Wang Cunlin, Member of the Expert Working Group of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and former Director of the Office of Pharmaceutical Epidemiology at the U.S. Food and Drug Administration (FDA); and Jia Ning, Director of the Administration Bureau of the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, delivered keynote addresses. The meeting was presided over by Cao Bing, Deputy Secretary-General of the People’s Government of Hainan Province.

In his address, Xu Jinghe stated that real-world evidence (RWE) is gradually becoming an important tool to support regulatory decision-making for pharmaceuticals and medical devices worldwide. Over the past five years, the pilot program for the application of clinical real-world data in Boao Lecheng, Hainan, has achieved breakthrough progress in practical applications. Twelve relevant guiding principles have been issued, and 17 imported pharmaceuticals and medical devices urgently needed for clinical use have been expedited to market. Going forward, efforts will be made to improve coordination mechanisms, refine the regulatory framework, diversify data sources, expand application scenarios, deepen international cooperation, and enhance governance capabilities.

Wang Cunlin delivered a keynote address titled “ICH M14 Update: Unified Guideline for Pharmacoepidemiology Studies—Standardizing Research Protocols, Design, and Analysis for Drug Safety Assessment Based on Real-World Data.” The presentation focused on the potential of real-world evidence in medical advancement, the objectives of the guideline, key principles, and the framework for generating sufficient evidence using real-world data, thereby elucidating the principles for assessing drug safety and efficacy through real-world data and real-world evidence.

Ning Guang delivered a keynote speech titled “High-Quality Development of Research-Oriented Hospitals Driven by the ‘Four Special Permissions’ Policy,” sharing the innovative achievements made by Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine (also known as Boao Research-Oriented Hospital in Hainan, hereinafter referred to as “Ruijin Hainan Hospital”) in the biomedical industry by leveraging the special permission policies of the Boao Lecheng International Medical Tourism Pilot Zone. He stated that, as an important branch of Shanghai Ruijin Hospital, Ruijin Hainan Hospital has conducted multiple real-world studies under the policy advantages of the Hainan Free Trade Port and the Lecheng Pilot Zone, utilizing the pilot program for real-world research in Lecheng. These efforts have provided new experiences and pathways to accelerate the market entry of global pharmaceuticals and medical devices in China. Moving forward, Ruijin Hainan Hospital will fully leverage the policy advantages of Lecheng and its own resource strengths to continuously advance the construction of a research-oriented hospital, strive to build a scientific highland for real-world studies, promote innovation in real-world data practices, and establish a world-class research-oriented hospital.

Jia Ning delivered a presentation on the theme of “Development and Opportunities of the Healthcare Industry in Boao Lecheng under the Hainan Free Trade Port Policies.” He stated that, with strong support from the National Medical Products Administration (NMPA) and other ministries, and under the correct leadership of the Hainan Provincial Party Committee and Provincial Government, the Boao Lecheng Pilot Zone has leveraged institutional integrated innovation as a key driver. By fully capitalizing on the dual advantages of policies for特许 drugs and medical devices and real-world study (RWS), the pilot zone has, after five years of exploration and effort, advanced the application of clinical real-world data (RWD) from an initial exploratory phase to one yielding tangible results, making positive contributions to accelerating the development of the pharmaceutical industry in Hainan and across China. Looking ahead, the Boao Lecheng Pilot Zone will further unleash its multifaceted advantages, conduct in-depth research on RWS standard systems, expand the scope of RWD applications, strengthen domestic and international exchanges and cooperation in real-world studies, and continuously deepen and solidify the pilot work on RWD application, thereby playing a greater role in promoting the rapid development of the biopharmaceutical industry.

In accordance with the relevant guidelines issued by the National Medical Products Administration (NMPA) and in light of the practical realities of real-world studies in the Boao Lecheng International Medical Tourism Pilot Zone, Lecheng has established China’s first regional platform for the collection, governance, and application of real-world data. Characterized by innovations in mechanisms, technology, regulation, and services, this platform represents a significant practice and exploration in establishing new standards, methods, and tools for real-world studies in China. It holds substantial significance for advancing the reform of China’s drug and medical device review and approval system.

In this innovative “testing ground,” real-world research has already taken solid and highly pioneering steps, deeply embedded in the entire process “vein” from approval to post-market monitoring, and continues to broaden the boundaries of exploration.

Geng Zhonghao, International Relations Specialist for Medical Devices at the U.S. Food and Drug Administration (FDA) China Office, delivered a presentation titled “U.S. FDA: Application of Real-World Evidence in Regulatory Decision-Making.” He pointed out that the FDA has been continuously exploring the use of real-world evidence (RWE) in regulatory decisions for medical devices and pharmaceuticals, and expressed its desire to further coordinate and collaborate with the Hainan Lecheng Pilot Zone to enhance data quality and transparency, thereby jointly promoting the development of real-world research.

In addition, the conference featured a plenary session and seven parallel thematic sessions on Real-World Studies and Clinical Evaluation of Drugs, Real-World Studies and Clinical Evaluation of Medical Devices, Real-World Studies and Pharmacovigilance, Real-World Studies and Biostatistics, Real-World Studies and Information Technology, Real-World Studies and Rare Diseases, and Real-World Studies and Clinical Evaluation of Traditional Chinese Medicine. These sessions focused on hot topics in the field of real-world research, shared cutting-edge research findings, and jointly promoted industry development.

Since June 2019, when the National Medical Products Administration and the People’s Government of Hainan Province jointly launched the pilot program for the application of real-world data in clinical settings (hereinafter referred to as the “pilot program”) in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan (hereinafter referred to as the “Lecheng Pilot Zone”), the past five years have yielded substantial achievements: 17 pharmaceutical and medical device products have leveraged real-world evidence to support their accelerated approval and market launch in China; 12 guidelines related to real-world studies have been issued, positioning the development of its guideline system among the international leaders.

These remarkable achievements fully demonstrate the effectiveness and value of the pilot initiatives undertaken in the Boao Lecheng International Medical Tourism Pilot Zone, providing strong evidence of its mature and high-quality environment for real-world data (RWD) applications. Leveraging these advantages, the Pilot Zone has transformed from an initial “testing ground” for pioneering reforms into a “powerful magnet” that gathers top-tier resources and stimulates innovative thinking, attracting numerous pharmaceutical and medical device companies as well as healthcare institutions to actively engage in this dynamic hub of innovation.

Currently, the Boao Lecheng International Medical Tourism Pilot Zone has become an increasingly popular choice for innovative pharmaceutical and medical device companies as well as healthcare institutions. More than 80 domestic and international pharmaceutical and medical device enterprises, including Boston Scientific, Novartis, Pfizer, and Zai Lab, have successively established their presence in the zone. Thirty-two healthcare institutions, such as Ruijin Hospital Hainan Hospital (Hainan Boao Research Hospital) affiliated with Shanghai Jiao Tong University School of Medicine, West China Lecheng Hospital of Sichuan University, and Boao Super Hospital, are thriving. Over 180 pharmaceutical and medical device companies from more than 20 countries and regions worldwide have established in-depth cooperative relationships with the Lecheng Pilot Zone. Moreover, top 30 globally ranked pharmaceutical and medical device companies are extending olive branches to the Lecheng Pilot Zone, seeking win-win cooperation opportunities.

To foster a pharmaceutical industry ecosystem, the Hainan Provincial Medical Products Administration and the Boao Lecheng Pilot Zone Administration, in collaboration with national drug regulatory authorities, are committed to establishing a pre-communication service system for real-world studies of medical devices. This system facilitates early intervention by engaging at the inception of real-world study projects to gain comprehensive understanding; provides full-process guidance by tracking each project phase and offering professional advice to address issues and ensure standardized progress; and enables timely communication to facilitate rapid information exchange among all parties, thereby preventing delays in research implementation due to information lags.

Meanwhile, the Boao Lecheng International Medical Tourism Pilot Zone has established an Ethics Review Committee and a Hainan Regional Service Center for the Management of Human Genetic Resources. The Ethics Review Committee oversees research ethics standards to effectively safeguard the legitimate rights and interests of study participants, while the Hainan Regional Service Center for the Management of Human Genetic Resources is responsible for coordinating and managing related resources, ensuring their compliant utilization, and laying a solid foundation for pharmaceutical and medical device research.

Furthermore, with Ruijin Hainan Hospital and West China Lecheng Hospital as the core, the Lecheng Pilot Zone is striving to build an international multi-center clinical trial platform for pharmaceuticals and medical devices. By leveraging the advantages of these hospitals, integrating resources from multiple parties, strengthening collaboration, and improving the efficiency and quality of clinical trials, the zone aims to expand the scope of research coverage.

The Boao International Conference on Real-World Studies of Pharmaceuticals and Medical Devices has become a key platform for continuously advancing the Ledong Pilot Zone as a global hub for resource aggregation, achievement demonstration, and exchange and cooperation in real-world studies of pharmaceuticals and medical devices. In the future, the Ledong Pilot Zone will continue to serve as a frontier for China’s real-world research, contributing the “Hainan Opportunity” and “Chinese Wisdom” to the global development of real-world evidence studies.

References:
1. Five Years of the Lecheng Real-World Study Pilot: From Spotlight Success to Widespread Impact, Sharing the “Hainan Opportunity” with the World. China Medical News