Regulatory Affairs

Your fastest route to the China market

千里之行, 始于足下

“A journey of a thousand miles begins with a single step.”

– Laozi

At CSC we understand that you want to get your asset to market as soon as possible, with no room for setbacks. But the Chinese regulatory environment is notoriously difficult to navigate, and at times, can be quite volatile. That’s why it’s important to have access to experts on the ground that are in constant communication with regulatory bodies and that stay ahead of industry-level changes, so that your submissions are always on the fastest route to market.

“Which regulatory path should our product take in China?”

“Is our product eligible for Priority Review?”

“Do we need to conduct a registration from scratch, or can we use data collected abroad?”

Since the CFDA changed to the National Medical Product Association (NMPA) in September, 2018, we have seen some major improvements in the regulatory landscape. Some of the best changes that may affect your path include:

1. Clinical Trial Application (CTA) process reduced from ~18 months to just 3 months (60 working days)
2. NMPA is “willing to consider foreign data” to support submissions
3. Significant improvements in IP Protection

There has never been a better time to approach the China market or include China in your global clinical development strategy.

How we can help:

1. Regulatory Consultation
2. Regulatory Strategy & Plan
3. Regulatory Package Preparation, Submission & Follow-up
   • Gap Analysis
   • Interact with Regulatory Bodies
   • Document Translation