China implements key regulatory changes to accelerate drug approval

by | Dec 19, 2019 | Uncategorized

China pharma sector, the second largest in the world, continues to grow rapidly on a CAGR of 10%, which will reach ~$393 Billion in 2025. 

Key regulatory changes

•   China Joined ICH in 2017: fast drug approval and match the global standards
•   NRDL (National Reimbursement Drug List) revision: volume expansion to offset price cut
•   New IND review: NMPA (Chinese FDA) has 60 business days to conduct its IND review
•   Acceptance of foreign clinical data: Data generated overseas will be considered acceptable if it complies with the NMPA’s requirements
•   Orphan drugs regulation: expedited approval and value-added tax
•   4+7 program: national drug centralized procurement pilot scheme to improve affordability and assure quality
•   Amendments to the Drug Administration Law: Implementation of drug market authorization holder system; Drug innovation incentive; Development of a drug traceability system

For biotech and medtech companies outside of China, the doors are open and opportunities arise. You need to find the right partners and resources in order to bring your products to China. The Company Presentation Track at China Focus @ San Francisco is designed for that. 

Apply now to present your company to these investors and big Chinese biopharma companies!

Gain Insights in Dealmaking by Hearing Real-World Case Studies

Would you be interested in hearing from executives who have closed rounds from Chinese investors or deals with Chinese companies? We have invited 6 executives to share their success stories and experience at China Focus @ San Francisco, followed by a Q&A session. 

We would also like to invite you to join us at the “Will China Focus help achieve your goal this year at the JPM week?” webinar to know more about China Focus, as well as opportunities to present your business at the conference. 

Date & Time: Dec 18, 2019 8:00 PM, Central Time (US and Canada)

  • What China Focus can bring to you
  • What’s unique about presenting at China Focus
  • What’s the process of company presentation

Estimated Duration: 30 mins
Speaker: Miao Guo Smith, MBA, VP, Operations
               Dr. Ginger Ding, Director, Investment Analyst