This webinar focused on current and emerging NMPA regulatory activities in China related to the use and approval of excipients:
1. Evolution of excipient regulations in China
2. Regulatory management requirements and communications strategies for excipient producers and users
3. Regulatory compliance challenges, CHP compliance, and bundling evaluation
4. Open discussion, 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 excipient management 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