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Laws & Regulations

Policy updates (as at 16th July 2019) (56th Announcement in 2019)

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.