Drug Regulation in China - Webinar Recording/Transcript
Drug Regulation in China: Updates, Key Issues and Common Challenges
Do you do business in China? Or consider entering the Chinese market?
With the fluidity — and uncertainty — of today’s regulatory environment, you must understand exactly what China has implemented, what is pending and what the near future holds.
John Balzano, Esq., a partner at Covington & Burling LLP, will provide you with an up-to-date understanding of China’s ever-changing drug regulations, including the proposals to the Drug Administration Law, Drug Registration Regulations, related guidance documents and Human Genetic Resource (HGR) regulations.
Mr. Balzano will present key issues and common challenges for companies navigating the drug regulatory lifecycle in China.
- Important new regulatory reforms in China related to drug development, including 60-day notification of clinical trial applications, priority review and GCP enforcement
- Revisions to HGR regulations, such as the new notification system and the continued approval system for exploratory research
- How to prepare for overseas inspections and compliance with emerging distribution and manufacturing rules
- How to make sense of the recent guidance documents coming out of China including guidance on foreign data and new application modules
Make the recent drug regulations in China work for you.