This webinar is about China Drug Master Filing (DMF) versus EU and U.S DMF. Accestra will provide an overview of the DMF registration systems covering Active Pharmaceutical ingredients (APIs), Excipients & Packaging Materials. Thanks to global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF, CEP and Japanese DMF requirements. However, local regulations and differences still exists and it is essential to understand these to minimize risks and issues further down the line with DMF submissions to China CDE & NMPA.
In this webinar you will learn:
- China Regulatory Framework
- DMF Registration Pathways & Strategies
- Comparison of China DMF with EU & U.S
- Technical requirements: Pitfalls & Tips
- Q & A (10-15 minutes)
April Wang, Business Development 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 registration projects during daily work. Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE and a successful track record with supporting international pharma with market entry into China including big and small pharma.
Helen Ye, General Manager at Accestra Consulting
Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customized solutions to international pharmaceutical companies and government institutions. She leads the registration team to plan, develop and implement compliance strategy for top pharma clients and with successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and others. Ms. Ye has strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China.
This webinar is sponsored by Accestra, a professional China Regulatory Affairs
Outsourcing agent to support pharmaceutical companies with drug & medical device registration with China NMPA (Formerly CFDA) including services related to China Drug Master File (DMF) for APIs, Excipients & Packaging Materials, Pharmaceutical Drug registration, pharmacovigilance and others. For info email: firstname.lastname@example.org