Leaders discussed the Real World Data (RWD) Pilot Program -- a cost-effective and less time-consuming alternative to the traditional clinical trial -- at a meeting in Boao, Hainan Province. China's NMPA (CFDA) hosted the meeting on October 10-11, joined by National and Hainan Provincial NMPA officials and eight overseas manufacturers, including one represented by China Med Device.
RWD will become another clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program through Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval. This is especially significant for manufacturers with high price tags, as RWD program participants can generate clinical data in the actual clinical environment with service fees whereas the traditional clinical trial needs to be complimentary.
Certain protocols and guidelines need to be followed for the RWD to be admitted as part of the clinical evidence for submission. The China Med Device client who participated in this pilot program will benefit from this new policy.
Hainan is the first province to pilot RWD in China. It offers an additional clinical option to the currently available clinical pathways such as clinical evaluation report and overseas clinical data acceptance. As RWD can be used prior to national NMPA approval, it can significantly shorten the time to begin selling devices in China.
RWD is the second major policy incentive for overseas manufacturers going into Hainan. The first is the status of 'first independent province for imported medical device approval'. "Imported medical devices can be clinically used in Boao City, Hainan province without national NMPA registration approval, as long as they are approved by Hainan Province NMPA office", announced by China State Council on April 4, 2018.
If you have any idea about RWD in China, or want to have an English copy of Hainan RWD Implementation Plan, please leave your comment here or email me at gpalma@ChinaMedDevice.com.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------