On December 8, the first Boao International Conference on Real World Studies of Medical Products was held in Hainan Province, with the theme of “Real World Data Studies and Innovative Development and Supervision of Medical Products”.
Hainan Boao Lecheng International Medical Tourism Pilot Zone, as the unique “Medical Special Zone” in China, is the only pilot region that makes active use of real data application. In recent years, it has grown into the most important channel for international innovative medical devices to enter China, initially achieving the synchronization with the international advanced level in the three areas of medical technology, equipment and medicines.
Feng Fei, Governor of Hainan Province, said in his speech that since 2019 Lecheng Pilot Zone had established in-depth cooperation with more than 80 medical device enterprises in 16 countries and regions. More than 270 kinds of medical products that are in urgent clinical need have been introduced from overseas. A total of nine kinds of products have been approved for listing in China through the use of real-world data from Lecheng to supplement clinical evaluation. “I sincerely hope that experts, scholars, guests and friends attending the meeting will have in-depth discussions and exchanges to promote Lecheng Pilot Zone to become a new highland for real world study and a new engine for the development of China’s pharmaceutical industry,” Feng Fei said.
According to Gauden Galea, WHO representative in China, with the rapid development of information technology and data science, real world data, study and evidence have had a wide-ranging and far-reaching impact on regulatory decisions. China is actively planning to apply real world data study to innovate the evaluation and regulation of products.
The main forum and eight parallel forums were set up at the conference, gathering the resources from domestic and foreign medical regulatory agencies, scientific research institutes, medical institutions, academic associations, medical equipment enterprises, etc., and presenting the phased research results at home and abroad, and jointly building a real-world research exchange platform.
Source: Hainan Boao Lecheng International Medical Tourism Pilot Zone