Back then, the idea of using real-world data in regulatory submissions sounded experimental.

Regulators stuck to traditional trials, and manufacturers had few alternatives.

But things have changed.

Real-world data (RWD) is now seen as a valuable resource to support regulatory decision-making.

Agencies in the US, EU, UK, Australia, Singapore, Japan, and South Korea have published guidance documents and opened the door for RWD in medical device approvals.

Interestingly, China chose its own stage to test the waters on an island province (Hainan) far from Beijing.

But why Hainan?

A few national initiatives set the stage.

Back in 2013, Boao Lecheng zone in Hainan province was designated as the country’s international medical tourism pilot zone.

Chinese patients have earlier access to cutting-edge imported devices that take years to clear the NMPA process.

Devices with urgent clinical need could be used clinically without full national registration.

In 2018, China designated Hainan as a Free Trade Port and a “special reform” zone. Its geography made it the perfect sandbox.

As an island province, it‘s easier to control cross-border use and data flow compared to large mainland regions.

This provides more freedom to experiment with policies that the rest of China wasn’t ready for.

If you read Part 1, you know the possible use cases of RWD proposed by NMPA.

This time, let’s dive into how China actually puts it into practice.

 🍜 Pilot Programs in China

The dot was connected when NMPA and the Hainan Provincial Government jointly launched a pilot program in June 2019.

Boao Lecheng’s advantage lies in two preferential policies that exist nowhere else in China:

• Patients can use medical devices and pharmaceuticals licensed abroad, but not yet available in China.

• Manufacturers can generate and use the RWD as local clinical evidence to bridge the gaps and support national registration.

By 2024, 13 pilot products were approved through RWD submissions. Among these, 4 were pharma drugs and 9 were medical devices.

We’ll look at three examples of the devices that succeeded and the regulatory strategies manufacturers used to get there.

🍜 XEN® Glaucoma Drainage Gel Stent

The first success story came from AbbVie. In March 2020, XEN® Gel Stent was the first medical device approved using domestically collected real-world data.

It’s a tiny surgical implant, designed to lower intraocular pressure in patients with refractory glaucoma.

AbbVie would have needed to run a full local clinical trial to prove safety and effectiveness in Chinese patients.

Instead, Abbvie gathered data directly from clinical use in Boao Lecheng.

Hospitals captured data through their electronic health records, procedures, surgical follow-ups, and some patient-reported outcomes.

This registry-style approach built a picture of how the device performed in real-world settings.

AbbVie showed that a strong safety and effectiveness record from overseas patients also applies to Chinese patients.

By leveraging RWD, the company avoided running new local trials while still addressing potential differences in patient population.