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Excipient and Drug Regulations in China; Interpretation and Management Strategies










Wednesday, August 17, 2022, 8:00am - 10:00am EDT

This webinar will focus on current and emerging NMPA regulatory activities in China related to the use and approval of excipients, including but not limited to:
1. Evolution of excipient regulations in China
2. The regulatory management requirements and the coping strategies of cooperation between excipient producers and users for global companies
3. Regulatory compliance challenges and key advice on China excipients filing, CHP compliance and bundling evaluation with drugs
4. Open discussion and interaction and Q&A

Learning/Awareness Objectives
1. Understanding the evolution of bundling review from registration to joint review of excipients used in drug products
2. Overview of the China pharmaceutical regulatory bodies and major responsibility for excipients managements for bundled review and approval with drugs
3. Concerns with current excipient registration document requirements in China and suggestions for a registration strategy, and change management
4. Review of current and future ChP development

Who should attend?

> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs