The China module provides a comprehensive overview of the Chinese regulatory system. There are more than 100 reference texts with English translations which include information on:

• The organization and function of authorities, the State Food and Drug Administration (SFDA), and the Ministry of Health (MOH)
• The China Drug Administration Law and its regulations for implementation
• Good manufacturing and clinical practice
• Types of business licenses and applications required for the registration of medicinal products
• The step-by-step review procedure of Chinese clinical trials approval and marketing authorization approval
• Advertising, promotion, fees, pricing, and reimbursement, for medicinal products in China
• Chinese guidelines including GMP, GLP, GCP, GRP, and GSP
• Chinese ADR monitoring and reporting system

For more information, download our China module factsheet.