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Document required for API registration in China

PART I Summary Information table of pharma study

PART II Summary document

Name of the Drug

Certified Documents

  1. 1) Free Sales Certificate (WHO format) which needs to be notarized by local notary and legalized by the Chinese Embassy in the manufacturer’s country.

  2. 2) GMP certificate ( WHO format) which needs to be notarized by local notary and legalized by the Chinese Embassy in the manufacturer’s country.

  3. 3) Authorization Letter which authorize the registration agent to register your product in China and it needs to be notarized by local notary.

  4. 4) Non-infringement statement, signature and company seal is enough. 

  5. 5) If the API has CEP, please provide CEP and its attachment. It needs to be notarized by local notary and legalized by the Chinese Embassy in the manufacturer’s country. 

  6. 6) If the API has DMF number, please provide DMF number and the dosage form approval and formulation manufacturer’s GMP certificate

  • Objectives and basis of the application: 

  • Self-assessment Report: 

  • Innovator Drug Product Information

  • Quality Overall Summary of the API

  • Draft of package and label 

PART III  DMF document (CTD format)


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