A Real World Data Research Seminar in Hainan

On July 10, 2020, a Real World Data Research Seminar was held in Lecheng (Hainan). Directors of local government and experts/researchers of real-world data research attended this seminar. They briefly introduced the basic situation of Lecheng Pilot Zone, the approval process of the first approved medical device (“XEN” manufactured by Allergan), key points of clinical protocol design and the interpretation and application of real-world date.

CMDE, NMPA sends seasoned experts Hainan taking temporary or regular posts to guide clinical real-world data application research on the spot. Under the guidance of CMDE, Hainan NMPA is exploring a pathway to convert these data into the real-world evidence that can be applied in the product registration in China. Moreover, this will accumulate experience for not only the reform of the China medical device review and approval system but also accelerating the accessibility of international innovative drugs and medical devices in China.

Lecheng Pilot Zone is one of the 11 key areas in Hainan Free Trade Port. The first approved medical device using real-world clinical data from Lecheng Pilot Zone has boosted the confidence of international manufacturers. It may accelerate the entry of imported drug and medical devices into China. Twelve global leading pharmaceutical companies including Johnson & Johnson, Medtronic, Boston Scientific, Pfizer, etc. have signed a strategic cooperation agreement with Lecheng regulatory Authority. The world’s top pharmaceutical company Sanofi has established a real-world research center in Lecheng Pilot Zone.

Bradynuoen was honored to attend this seminar with an opportunity to communicate with experts in Lecheng. This face to face communication with the primary investigator and statisticians of Allergan expatiated the approval process of medical devices with real-world data, their experience in the application process, the product approved process and key points of clinical protocol design. If you want to know more details about the registration pathway in Hainan, please do not hesitate to contact us at info@inspirativemed.com.