BOAO, China, Nov. 29, 2024 — The third Boao International Conference on Real World Studies of Medical Products successfully concluded in Boao, Hainan Province, China, from November 23 to 24. More than 800 attendees participated, representing international organizations, drug and medical device regulatory agencies, leading medical institutions, top research universities, and major pharmaceutical and medical device companies.
Global regulatory agencies increasingly value real-world studies for their crucial role in evaluating and approving drugs and medical devices. Real-world data is also recognized as a vital resource for global regulatory decision-making.
The Boao International Conference on Real-World Studies of Medical Products, a key global and Chinese platform for this field, has successfully convened for three consecutive years.
Hosted by the Hainan Lecheng Institute of Real World Study, this year’s conference focused on “Real-World Studies Facilitate Clinical Evaluation of Innovative Drugs and Medical Devices.” The program included a plenary session and seven thematic sessions: (1) RWS and Clinical Evaluation of Drugs; (2) RWS and Clinical Evaluation of Medical Devices; (3) RWS and Pharmacovigilance; (4) RWS and Biostatistics; (5) RWS and Information Technologies; (6) RWS and Rare Diseases; (7) RWS and Clinical Evaluation of TCM. The conference facilitated the exchange of regulatory science insights and advanced research, promoting industry progress.
The Boao Lecheng International Medical Tourism Pilot Zone is China’s sole “medical special zone” and its first pilot area for real-world data application. It aims to become a leading international medical tourism destination and a hub for medical technology innovation.
In 2019, the Hainan Provincial People’s Government and the National Medical Products Administration (NMPA) jointly initiated a pilot program for using clinical real-world data in the Boao Lecheng pilot zone. Over the past three years, the Boao International Conference has become a central platform for global collaboration and resource sharing in real-world studies. The conference has included contributions from international organizations like the WHO and CIOMS, and regulatory agencies including China’s NMPA, the US FDA, the EU EMA, Japan’s PMDA, and Singapore’s HSA. Experts from research institutions and multinational pharmaceutical and medical device companies have presented cutting-edge research and regulatory advancements.
“The Lecheng pilot zone presents ample opportunities for real-world studies. The FDA will continue to strengthen coordination and collaboration with Lecheng to improve the transparency and quality of real-world data, fostering the global advancement of real-world studies,” stated Scott C. Gonzalez, International Relations Specialist – Medical Devices, FDA China Office, at the conference.
Since the launch of the clinical real-world data application pilot program five years ago in the Lecheng pilot zone, 40 international innovative drugs and medical devices have been studied under real-world data application projects. Of these, 17 products—including five drugs and 12 medical devices—have received Chinese registration and market approval.
The Lecheng pilot zone currently partners with over 170 pharmaceutical and medical device companies from 20 countries and regions, introducing over 440 urgently needed imported drugs and medical devices. Leveraging its special policies for drugs, medical devices, and real-world research, the inaugural Lecheng Business Development (BD) Conference was held concurrently in Boao.
The Lecheng BD Center showcased over 100 innovative products online, including biopharmaceuticals, medical devices, and specialty foods from China and abroad. The first group of resident projects also secured same-day transactions, accelerating the industrialization of innovative medical advancements and providing biopharmaceutical companies with access to China’s wellness market.
Source: The Hainan Lecheng Institute of Real World Study
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