Snapshot

The Conditional Approvals for New Drugs pathway has been developed by the National Medical Products Administration of China.

This pathway can be used where 1. Medicinal products used to treat serious and life-threatening diseases for which no effective treatments are available, if efficacy has been verified by clinical trial data and if the clinical value can be predicted. 2. Medicinal products urgently needed for public health if efficacy has been demonstrated by clinical trial data and if the clinical value can be predicted. 3. Vaccines needed for major public health emergencies or vaccines that are urgently needed as identified by the National Health Commission, if benefits outweigh risks according to evaluation. .

It is an abridged review (a reliance pathway).

70 working days for urgently clinically needed drugs and rare disease products not yet available in China.