Building upon the foundational insights presented in the first article of our China series, this subsequent piece delves deeper into the intricacies of China’s drug master file (DMF) registration pathways. Focused on active pharmaceutical ingredients (API), excipient and packaging material products, this article provides a crucial analysis of these pathway options.

By illuminating the advantages and considerations inherent in each of the options, this article aims to empower DMF applicants with the knowledge necessary to strategically optimise their registration processes within the dynamic regulatory environment of China. This comprehensive exploration serves as a valuable resource for industry professionals seeking to navigate and excel in DMF registration in China.