Overview:

On December 2022, a new template Drug Export Sales Certificate has been launched, which conforms to the format recommended by the World Health Organization (WHO).  Electronic certificates have the same effect as paper certificates.

Introduction

To improve the “Internet + drug supervision” service capacity of the National Medical Products Administration (NMPA), and make services more efficient and convenient, the NMPA will provide drug exporting companies with more efficient administrative services, and it has been decided that electronic certificates of Documentation for Exporting APIs to the EU and Pharmaceutical Product Certificate will be officially put into use from December 1, 2022.

When does the Issuance of Electronic Certificates begin?

  • From Dec 1, 2022, the electronic certificates of the Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product will be put into use.
  • The electronic certificate and the paper version are equally authentic.
  • From Dec 1, 2022, all provincial-level drug regulatory authorities shall issue the Certificate of a Pharmaceutical Product in accordance with the new template.
  • The electronic certificate and the paper version are equally authentic.
  • On December 1, 2022, all provincial-level drug regulatory authorities will issue the Certificate of a Pharmaceutical Product in accordance with the new template.
  • The template of the Certificate of a Pharmaceutical Product will be put into use in accordance with China’s pharmaceutical export practices and the latest guidelines of the World Health Organization.

Guidance Manual for using of electronic certificates portal

  • To use the electronic certificate produced and issued by NMPA’s application system, the applicant must first register and be authenticated with the real name in NMPA’s Online Office Room. Enter the “My Certificates” section (Chinese name in Pinyin: Wodezhengzhao) in the legal representative’s space in the Online Office Hall, or log into the NMPA APP (Chinese name in Pinyin: Zhongguoyaojian) to view and download the corresponding electronic certificate.
  • Frequently asked questions and answers related to electronic certificates produced and issued by NMPA can be found in the “Help for Electronic Certificate Related Issues” column in the NMPA Online Office Hall.
  • When electronic certificates produced and issued by the provincial enforcement system are used, the provincial drug regulatory department shall clarify the relevant guidelines for businesses within its administrative region and provide guidance and services.

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References

Learn more about NMPA. For the link, click here (Only available in Chinese).

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