Event signals 'return of overseas medical consumption'

Hainan's Boao Lecheng International Medical Tourism Pilot Zone appears to have taken the lead in real-world studies of drugs and medical devices worldwide, industry practitioners said.

They expressed their views at the first Boao international conference on real-world studies of medical products in Boao, Qionghai city, on Thursday.

Themed "Real-world data research and innovation and development of drug and medical device supervision", the event attracted more than 50 speakers from home and abroad.

Real-world studies are based on the clinical evidence on the usage and potential benefits or risks of a medical product. Such evidence is derived from analysis of data relating to patient health status or the delivery of health care. Such data, in turn, are routinely collected from a variety of sources. Studies are believed by many industry practitioners to be key to transforming healthcare in the future.

The Lecheng pilot zone is the first and only pilot area in China where real-world data can be widely used. Since the pilot project of clinical real-world data application was launched in June 2019, the Lecheng pilot zone has established in-depth cooperation with more than 80 medical device companies in 16 countries and regions.

It also introduced more than 270 medical devices that are urgently needed in clinical practice abroad. Some nine products have been approved for marketing through the use of Lecheng real-world data-assisted clinical evaluation, said Feng Fei, governor of Hainan province.

While new drugs already marketed overseas apply for registration in China, the use of real-world data support is expected to accelerate the approval needed to enter the Chinese market.

Relying on the real-world data application pilot work, the Lecheng pilot zone has introduced more than 20 foreign innovative medical devices in the last four years. With the support of real-world data, nine of them have been approved in China at an accelerated pace, which demonstrates Hainan's contributions to patient care across the country.

"The pilot work is a major exploration in the reform of the national drug and medical device review and approval system, an important practice and innovation in Chinese drug regulations and one of the major institutional innovations in Hainan province," said Zhu Ning, director of the Hainan Provincial Food and Drug Administration.

"The accelerated approval of trial varieties through the use of real-world research data to assist the evaluation has a very important and positive role in accelerating the launch of global innovative products in China, further promoting the reform of the drug and medical device review and approval system, and better meeting people's health needs."

Gauden Galea, the WHO representative in China, said that China has been exploring the use of realworld data to evaluate and regulate innovative medical products through the release of national guidelines, publication of technical documents, and launch of pilots such as the one in Boao Lecheng.

"In the last four years, with support from the National Medical Products Administration, Hainan has actively carried out real-world evidence collection and research and explored its use in regulatory decision-making," said Wang Bin, vice-governor of Hainan province. "Hainan has explored new methods and provided new solutions for accelerating the accessibility of global innovative medical and device products in China."