Last Up in Our China Series: Clinial Trial Regulations

building with flags representing china clinical trial regulations

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. We’ve explored both of these features in our recent posts on clinical research in Europe and China – 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 wrap up our investigation of growth in China’s clinical trial market, we’re focusing on some of the regulatory reforms the Chinese government issued in 2015, which have been a major driver in China’s recent growth. 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, and facilitating discovery in Phase I pharma studies. Let’s take a look at a few of these reforms.

3 big updates to China’s clinical trial regulations

1. Accelerated approvals
Until 2015, pharma companies doing research in China had to wait for explicit approval of clinical trial applications from the Chinese Food and Drug Administration (CFDA). This, of course, is not abnormal, and wouldn’t be so burdensome if not for the fact that the CFDA typically took about 200 days – more than six months – to issue approvals. Now, the government has signaled that clinical trial applications will be considered approved if the CFDA doesn’t respond within 60 days. This has significantly reduced what had become a severe drug approval backlog in China, and has helped bring China’s clinical trial market into the mainstream.

2. A boost for Phase I
Updates to clinical trial regulations have also helped make Phase I a big part of China’s clinical trial market. Previously, there was virtually no such thing has Phase I in China – clinical trials for any drug could not take place there before the drug had reached Phase II in another country. As Phase I is, more so than other areas in clinical research, a venue for major medical and scientific discovery, this amounted to a big blow to innovation. But the 2015 reforms allow multinational companies to conduct Phase I trials in China for any product other than vaccines. This enables companies to significantly reduce costs in Phase I by conducting the trials at Chinese sites, where costs are often lower than in other clinical research hubs around the world.

3. Green-lighting overseas clinical trial data
China’s clinical trial regulations before 2015 required that data demonstrating a drug’s efficacy come from clinical trials conducted within the country’s physical borders. Now, regulators are accepting clinical data collected in trials conducted around the world, helping sponsor companies reduce R&D costs and pursue approvals in multiple geographies simultaneously.

We’ve learned a lot about the factors spurring growth in China’s clinical trial market while doing research for our China series. One of our biggest takeaways is that clinical trial regulations are the linchpin that any country’s clinical trial market fundamentally depends upon. Another is: with such abundant clinical trial opportunities in China, and such a wide range of innovative eClinical technology available to take advantage of them, there has never been a better time to be a clinical researcher.