The Priority Review pathway has been developed by the National Medical Products Administration (NMPA) of China.
This pathway can be used where 1. Innovative or optimised new medicinal products that are urgently needed during a shortage of supply to prevent and treat major infectious or rare diseases (orphans). 2. New medicinal products, dosage forms, and strengths for pediatric use, suitable for the physiological characteristics of children. 3. Vaccines urgently needed for disease prevention and control and innovative vaccines. 4. Medicinal products included in the Breakthrough Therapy Procedure. 5. Medicinal products included in the Conditional Approval Procedure. 6. Other circumstances of Priority Review and approval as specified by the National Medical Products Administration (NMPA)..
The marketing authorization application (MAA) review timeline is 130 business days. The MAA review timeline is 70 business days for medicinal products urgently needed for rare diseases and approved abroad but not within China. Where inspection, QC testing, and approval of the generic name are needed, priority will be arranged.