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Document required for API registration in China


  • Name of the Drug

  • Certified Documents

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

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

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

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

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 manufacturers country. 

6) If the API has DMF number, please provide DMF number and the dosage form approval and formulation manufacturers 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 

  • DMF Dossier of the API 


No.32 zhongxing road, zhangjiagang economic development zone, jiangsu province

+86 512 58988126  +86 13511624455  Miss Zhu

Zlisa@sanraypharm.com

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