#50: Understanding and Navigating the Regulatory System in China

At the conclusion of this tutorial, participants should be able to:

• Describe the regulatory system in China, including the agencies and institutions and their roles and responsibilities in the regulatory processes for clinical trial and registration approval, as well as safety reporting
• Explain the history and the recent changes in the regulatory system in China and future perspectives
• Describe the regulatory pathways and strategic considerations for successful clinical trial and marketing applications in China
• Discuss how to navigate the regulatory system in China for clinical trial approval and product registration.