The Hainan Lecheng Institute of Real World Study

Boao, China (ANTARA/Xinhua-AsiaNet)- The third Boao International Conference on Real World Studies of Medical Products was successfully held from November 23 to 24 in Boao, Hainan Province, China. The event attracted over 800 participants, including representatives from international organizations, regulatory agencies for drugs and medical devices, prominent medical institutions, top research institutes and universities, and multinational pharmaceutical and medical device companies.

In recent years, real-world studies have garnered widespread attention from regulatory agencies worldwide for their critical role in the evaluation and approval of drugs and medical devices. In addition, real-world data has increasingly been recognized as a key resource in supporting regulatory decision-making globally.

As a pivotal platform for international exchange in the field of real-world studies, both in China and globally, the Boao International Conference on Real-World Studies of Medical Products has been successfully held for three consecutive years.

Organized by the Hainan Lecheng Institute of Real World Study, this year's conference centered on the theme "Real-World Studies Facilitate Clinical Evaluation of Innovative Drugs and Medical Devices." The program featured 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 served as a vital platform for sharing insights into regulatory science and showcasing advanced research, fostering industry growth.

The Boao Lecheng International Medical Tourism Pilot Zone is the only "medical special zone" in China and the country's first pilot area for the application of real-world data. It is committed to becoming a world-class 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 launched a pilot program for applying clinical real-world data in the Boao Lecheng pilot zone. Over the past three years, the Boao International Conference on Real World Studies of Medical Products has emerged as a key platform for global collaboration and resource sharing in real-world studies. The conference has featured contributions from international organizations such as the WHO and the Council for International Organizations of Medical Sciences (CIOMS), as well as 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 also shared cutting-edge research results and regulatory advancements in the field at the event.

"There are abundant opportunities to conduct real-world studies in the Lecheng pilot zone. Looking ahead, the FDA will continue to enhance coordination and collaboration with Lecheng to further improve the transparency and quality of real-world data, jointly advancing the global development of real-world studies," said Scott C. Gonzalez, International Relations Specialist - Medical Devices, FDA China Office, during the conference.

Over the five years since the launch of the clinical real-world data application pilot program in the Lecheng pilot zone, a total of 40 international innovative drugs and medical devices have been studied under real-world data application projects. Among them, 17 products -- including five drugs and 12 medical devices -- have successfully received approval for registration and market entry in China.

To date, the Lecheng pilot zone has forged in-depth partnerships with over 170 pharmaceutical and medical device companies from 20 countries and regions, introducing over 440 urgently needed imported drugs and medical devices. Building on its special policies for drugs and medical devices and real-world research initiatives, the inaugural Lecheng Business Development (BD) Conference was held concurrently in Boao.

During the event, the Lecheng BD Center unveiled over 100 innovative products online, including biopharmaceuticals, medical devices, and specialty foods from both China and abroad. The first batch of resident projects also secured transactions on the same day, thereby accelerating the industrialization of innovative medical advancements and enabling biopharmaceutical enterprises to capitalize on new opportunities from China's wellness market.

Source: The Hainan Lecheng Institute of Real World Study