Date:19 September 2023
Time:15:00-16:00 (GMT)
10:00-11:00 (ET)
22:00-23:00 (Beijing Time)
WEBINAR INTRODUCTION
This webinar is about China Drug Master Filing (DMF) comparing with EU and U.S DMF. The presentation provides an overview of the DMF regulatory systems covering Active Pharmaceutical ingredients (API), Excipients & Packaging Materials.
Thanks to the global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF, CEP and Japanese DMF requirements. However, local requirements and gaps in the regulations still exists, and it is important to understand these to minimize risks and issues with China CDE & NMPA.
Key Takeaway Points
- China DMF Regulatory Framework & Registration System
- DMF Registration Pathways & Strategies
- Similarities and Differences between China DMF with EU & US
- Tips & Pitfalls
- Q&A
Presenter:
April Wang, Regulatory Affairs Manager at Accestra Consulting
- Ms. Wang is a senior regulatory affairs consultant supporting pharmaceutical companies with understanding Chinese regulatory requirements.
- She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & drug (both biologics and chemical drugs) registration projects during daily work.
- Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
- A successful track record with supporting international pharma with market entry into China including big and small pharma.
See you there!
– Accestra Events Team
