Article | March 14, 2019

3 Big Updates To Clinical Trial Regulations In China – And Why They Matter

Source: Medrio

By Nick O’Brien, Content Manager, Medrio

Regulatory Requirements For Medical Devices In China

Here’s a notion that may run counter to the conventional wisdom around what makes an ideal clinical trial destination: It doesn’t matter if a country’s healthcare and clinical research markets are full of brilliant innovators, or if it has a large population ripe for patient recruitment. At Medrio, we’ve explored the impact of both of these characteristics on the clinical trial markets of Europe and Asia - but neither of them can make those regions into clinical research leaders without strong support from one key area: the regulatory bodies.

That’s why updates to clinical trial regulations around the world - recent FDA actions we’ve covered, like releasing eSource and eConsent guidance and moving toward 510(k) updates, are just a few examples - have us so excited here at Medrio. These updates show that regulatory bodies, while maintaining their primary goal of ensuring the safety of market-approved drugs and devices, are also heavily invested in the clinical research community’s pursuit of the next big breakthrough.

As we focus on regulatory shifts in China’s clinical trials market, we’re focusing on some of the reforms the Chinese government issued in 2015, and which have been a major driver in China’s growth since then. One thing that struck us during our research was that these reforms were largely aligned with Medrio’s core values: accelerating clinical research, reducing clinical trial costs that slow the arrival of life-saving products, and facilitating discovery in Phase I pharma studies. Let’s take a look at a few of these reforms.