Simplifying Global Compliance
Drug Regulation in China - Webinar Recording/Transcript
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Drug Regulation in China: Updates, Key Issues and Common Challenges
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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.
Presentation Takeaways:
- 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.
- General Counsel
- Senior Counsel
- Deputy General Counsel
- Legal Counsel
- Regulatory Specialists
- Quality Specialists
- Compliance Specialists
John Balzano, Esq., a partner at Covington & Burling LLP, represents companies and business associations on U.S. and China regulatory and policy matters related to drugs, medical devices, food, cosmetics and other regulated products. He has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies and reviewing distribution and promotional plans. Mr. Balzano also advises on regulatory compliance, due diligence and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries and implementing product recalls. As part of his work, Mr. Balzano advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.
