Island Evidence: A Quicker Path to China’s Market via Hainan Province?

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China’s growing embrace of real-world evidence as a premarket regulatory tool is bolstered by a unique program in tropical Hainan Province, allowing companies to sell their devices and collect this type of data in advance of national approval.

Hainan Province is a popular beach resort region in China, but vacation-goers aren’t the only ones flocking to the region these days. The province, the southernmost in China consisting of Hainan Island and several smaller islands, is a growing point-of-entry to the country for new devices from multinational medtech firms. It’s also a staging ground for China’s growing acceptance of real-world evidence (RWE) to support premarket approval decisions. 

The province offers foreign companies an opportunity to gain early access to Chinese patients, physicians, and investors, before gaining marketing approval from the National Medical Products Administration (NMPA). Special government policies in the Boao Lecheng region of Hainan Island—billed as a destination for “medical tourism”—are meant to make innovative medtech developed overseas available to Chinese patients and avoid the need for travel to other countries to get needed treatments. 

Devices approved in other major countries that are deemed to meet an urgent need in China can be sold for a profit in Hainan, where investments by China’s government over the past decade have built a substantial hospital infrastructure. Manufacturers can invite physicians from mainland China to perform the procedures in Hainan, offering a marketing and training reach throughout China in advance of country-wide sales. And Hainan also has created forums for foreign companies to present their technologies to China-based investors who can ultimately help fund longer-term market access.   

“For some very innovative products, Hainan is like a stage where you can show your products to investors,” according to Tracy Yu, a general manager and co-founder of consulting firm BradyKnows Medical, which works with device firms to access the China market, including Hainan. “There are a lot of investors there in Hainan looking for new technology,” Yu said in an interview.

Perhaps even more importantly, programs in Hainan provide an opportunity to collect real-world data (RWD) to speed a firm’s path to national regulatory approval in China. And select devices can participate in a 2019-launched pilot program in Hainan, where NMPA plays a role in vetting a firm’s real-world study in the province so the data can be better targeted to support fast-track national review. So far, at least four companies have leveraged the fast-track pilot to gain national approvals that are among the first in China to rely, in part, on real-world evidence.  

But these programs are not the best option for every company seeking to access China, Yu cautions. Firms should “clearly know what their objectives are in Hainan, she says. “They should know what they need.”

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