The Chinese Food and Drug Administration (CFDA) has a reputation of complex regulatory hurdles standing between bio pharma companies and drug approvals. Thankfully, they’ve recently issued four new policies that can give an idea of what the official reform will look like.
Before the reform, foreign drugs had two options to gain Chinese approval. “One, come to China after the drug has been approved elsewhere and then conduct China-specific trials. Two, use China as part of multicenter clinical trials after the drug has at least been tested through phase 1 elsewhere—potentially beginning with phase 1 all over again.” A company with a potential drug must wait for an official authorization from the CFDA before they can even begin the trial. However, under the new proposal, the CFDA would have 60 working days to raise a concern with a trial application. If no issue is brought up within the 60 days, the application is automatically approved.
- The first proposed policy was designed to expedite the approval process for medical devices and drugs that meet urgent clinical needs.
- The second proposed policy aims to encourage innovation through reforming the existing clinical trial management policies.
- The third policy proposes to strengthen the market authorization holder (MAH) system in China. The MAH system is currently run in 10 Chinese provinces, but the CFDA intends to make it a nationwide system.
- The fourth proposed policy aims to increase intellectual property (IP) protection of pharmaceuticals. It proposes establishing a patent linkage system for drugs, similar to the U.S. system, requiring all pharmaceutical approval filings to be correlated with valid patents.
If adopted, these policies will allow for fundamental changes to China’s current system. Companies will want to carefully review the changes with a trusted distribution expert before entering China’s market.
What does this mean for digital heath startups?
If the proposed plan is successful, the changes will speed up the introduction process of new drugs from outside of China, primarily from companies operating in the U.S., Japan, and the EU. The CFDA will also begin training more reviewers for these imported drugs. If guidelines are approved, digital health companies across the globe should automatically include China in their clinical development plans.
The country has always been an ideal location for clinical drug trials thanks to the high volume of citizens in need of treatments and the low cost of conducting trials in China. However, with the new updated approval process, companies looking to import drugs for sale in China or conduct trials in China can now do so without the burden of a time-consuming approval process. Digital health startups should be ready to accommodate CROs and Sponsors who are likely to ramp up their efforts in China thanks to the updates. Ensuring the bilingual capabilities of your software, confirm the software can work on Chinese frequencies, and that any imported supplies include the CCC certification mark. Working with a trusted distribution partner with experience deploying devices and supplies in the Chinese market is ideal.