The second Boao International Conference on Real World Studies of Medical Products is held from Oct 31 to Nov 1 in Hainan province. [Photo provided to chinadaily.com.cn]
Nearly 1,000 guests from domestic and foreign pharmaceutical products regulatory agencies, scientific research institutions and associations, and medical products enterprises attended the second Boao International Conference on Real World Studies of Medical Products, which was held on Tuesday and Wednesday in Boao, South China's Hainan province.
The theme of the conference was "international real world data research and scientific development of medical products regulation". Participants discussed hot topics such as drug and medical device supervision, traditional Chinese medicine supervision, post-market safety evaluation of medical products, real world data research and specialized diseases, biostatistics, information technology, and medical and health economics.
"The conference is a feast of ideas for the research and exchange of real world studies of medical products," said Shen Danyang, deputy secretary of the Communist Party of China Hainan Provincial Committee.
He hoped that experts and scholars can use the platform to generate ideas, stimulate vitality, discuss problems, and seek development, in order to provide new methods, standards and paths for promoting real world studies in the field of pharmaceutical devices for regulatory decision-making in China and even the world.
The Hainan Boao Lecheng International Medical Tourism Pilot Zone, the first and currently only special medical zone in China, permits the introduction of innovative drugs and medical devices that are already listed abroad but have not been registered domestically for meeting urgent clinical needs. This allows Chinese people to access cutting-edge international medical technologies and products without having to go abroad. Lecheng has also initiated pilot programs for the application of clinical real world data, which harnesses the diagnosis and treatment data of specially permitted medical products to assist their registration evaluation and approval in China.
So far, it has introduced and used over 350 innovative drugs and medical devices that have not yet been launched in China. Thirteen products were registered in China through the use of real world data assisted clinical evaluation.
"It has played an important role in ensuring the health of Chinese people and attracting the return of medical consumption," said Jia Ning, director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. "Real world studies is a cutting-edge science. Many countries in the world have invested a lot in it, and I believe China has followed the international level through Lecheng."
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