China: CFDA New Drug Import License Procedure

AUTHOR: Reynaldo Roman

China Food and Drug Administration’s new import licensing procedure requires importers to apply for their CFDA import license online.

In an ongoing effort to modernize trade, China Food and Drug Administration (CFDA) announced that as of December 27, 2019, importers must apply for their drug import licenses via the China International Trade Single Window online platform. The agency will no longer accept paper applications.

Importers in China must register on the China International Trade Single Window to receive a user ID and password, which will then allow them to sign in to the platform and apply for their import license.

CFDA has also specified that for shipments of investigational medicines, only a party authorized under the corresponding Clinical Trial Approval (CTA) can register and apply for the import license.

Marken China is supporting importers by providing guidance and training on the online platform and successfully helping clients transition to the new licensing procedure.

Please send your questions regarding China’s new licensing procedures to tradecompliance@marken.com.

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