NMPA Announcement on putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product

(No. 95, 2022)

As part of the efforts to implement the major decisions and plans of the Communist Party of China Central Committee and the State Council on deepening the reforms to separate operating permits from business licenses, in order to further improve the business environment, stimulate the vitality of market entities, optimize the service capacity for "internet + drug supervision" of the National Medical Products Administration (NMPA), and provide drug export enterprises with more efficient and convenient administrative services, it is decided that the electronic certificates of the Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product will be officially put into use from Dec 1, 2022. Relevant matters are hereby announced as follows.

1. 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.

2. A new template for the Certificate of a Pharmaceutical Product (see annex) will be put into use in line with China's pharmaceutical export practices and the latest World Health Organization guidelines. From Dec 1, 2022, all provincial-level drug regulatory authorities shall issue the Certificate of a Pharmaceutical Product in accordance with the new template.

3. Efforts should be made to promote and guide the use of electronic certificates. To use the electronic certificate produced and issued by the application system of the NMPA, the applicant shall first register and be authenticated with real-name in the Online Office Hall of the NMPA. Enter the "My Certificates" (Chinese name in Pinyin: Wodezhengzhao) section in the legal representative 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. The applicant shall properly keep the electronic certificate. Frequently asked questions and answers related to electronic certificates produced and issued by the NMPA can be found in the column of "Help for Matters Related to Electronic Certificate" in the Online Office Hall of the NMPA.

4. Where electronic certificates produced and issued by the provincial application system are used, the provincial drug regulatory department shall clarify the relevant guidelines to enterprises within its administrative region and provide guidance and services.

It is hereby announced.

Annex: The template for Certificate of a Pharmaceutical Product (2022 Edition)

National Medical Products Administration

Oct 27, 2022