As an important part of promoting the reform of Chinese medical device review and approval system, the National Medical Products Administration (NMPA) is actively exploring the use of clinical real-world evidence (RWE) data for medical device product registration. In June 2019, the State Food and Drug Administration and the Hainan Provincial Government jointly launched the Hainan Clinical Real-World Data Application Pilot Project. On March 26, 2020, the NMPA approved the marketing application of the pilot’s first product which used clinical real-world evidence collected in the Hainan Boao Lecheng Medical Pilot Zone, providing new clinical evaluation pathways for medical device registration in China. There are increasing numbers of internationally leading medical devices that have entered the Hainan Boao Lecheng International Medical Tourism Pioneer Zone to collect RWE and provide data support for market authorization application in China.
About Hainan Boao Lecheng Medical Pilot Zone
In 2013, the State Council issued the approval on the Establishment of Hainan Boao Lecheng International Medical Tourism Pilot Zone. Through the "four franchise（4 个特许）" policy prioritizing franchised medical care, franchised research, franchised management, and franchised international medical exchange based on the "National Nine Articles" policy granted by the state ,the "three synchronizations（三同步）" of medical technology, equipment, and medicines with international advanced levels have become realised.
It is the only “special medical zone” in China that allows early market access for advanced international products.
The main preferential policies in the Medical Pilot Zone are as follows:
1) Products that have been approved by foreign countries but not yet approved in China can apply for approval in accordance with the requirements of special approval management regulations.
2) The pilot zone will be able to apply for and carry out clinical studies of advanced medical technology such as stem cell clinical research.
3) The number of years of practice required for foreign doctors who plan to work in the pilot zone is relaxed to three years on a trial basis.
About usefulness of RWE in clinical application
The application of RWE for clinical evaluation of Chinese registration can shorten the time and cost of product registration in China and can be applied to support clinical evaluation of medical devices throughout its life-cycle. According to the <Technical Guidelines for Clinical Evaluation of Medical Devices Using Real-World Data (draft) > issued by CMDE (Center for Medical Device Evaluation), RWE can be used in the following clinical evaluations:
1) Provide clinical evidence in the clinical evaluation pathway of medical devices for the same disease indications
2) Used to support product registration by supplementing existing evidence
3) The real-world data collected for the clinical use of the imported device in-country can be used to……
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