Biologics Approval & Accelerated Pathways in China

Topics:

• Fast-track registration pathways in China
• Special registration procedures in China
• Imported drugs for urgent clinical use & real world clinical data
• Case studies

China's drug registration process has undergone significant reforms aimed at simplifying application procedures and aligning with international standards since its membership in the ICH in 2017. This presentation explores China's accelerated pathways and pilot programs for drug registration, with a focus on urgent clinical use, rare diseases, pediatrics, breakthrough therapies, and more. It covers the definitions, procedures, requirements, and timelines associated with each pathway, accompanied by case studies highlighting successful registrations and imports. Attendees will gain valuable insights into leveraging these policies for faster market access to China.