Ø For overseas suppliers, API registration in China is to be done through an agent (Leawell for example). Submitted documents must be in Chinese.
Ø An official fee would be charged for DMF filing to the NMPA platform.
Ø For the API registered in the NMPA platform, the applicant (local agent) would be responsible for the maintenance and update of the registration information.
Ø For the status of registration, 3 status would be shown.
l “A”: The API has been completed association review with a FDF manufacturer in China. The API has been distributed commercially.
l “A*”: The API has completed technical review. But it has not link with any other FDF manufacturer in China for the association review.
l “A#”: The API has been distributed commercially. But there is a major change in manufacturing respective which affects the quality of the API. The major change has not been reviewed by NMPA yet.
l “I”: The API has not completed any technical review or association review with any other FDF manufacturer in China.
Ø For holders of valid IDLs, the registered API will automatically be transferred to the NMPA platform.