2020 China Drug Evaluation Report – Part 3
Part 3. Administrative Approval and Fast Track Review Pathways Table of contents Administrative approval. Fast track review pathways. 2.1. Specialized pathway. 2.2. Breakthrough therapy. 2.3. Conditional approval. 2.4. Priority Review. In 2020 CDE approved: 1,435 Investigational New Drug (IND) applications, 208 New Drug Applications (NDAs), 918 Abbreviated New Drug Applications (ANDAs). This includes 59…