In order to implement the decision and deployment of the CPC Central Committee and the State Council’s important decision to deepen the reform to delegate power improve regulation, and upgrade services, improve the business environment, further stimulate the development vitality of market entities, and provide more efficient and convenient government services for enterprises, it is decided to issue the electronic drug registration certificates for pharmaceutical products from November 1, 2022. The relevant matters are hereby announced as follows:

　　I. The scope of the issuance of the electronic drug registration certificates are those from November 1, 2022, approved by the NMPA for the certificates for clinical trials, marketing authorization, renewal of drug registration, supplementary applications, traditional Chinese medicine variety protection, imported medicinal materials, chemical active drug ingredients etc. as well as the GLP document.

　　II. The electronic drug registration certificate has the same legal effect as the paper certificate. The electronic certificate has the functions of instant delivery, SMS reminder, certificate authorization, code scanning verification, online verification, whole network sharing, etc.

　　III. The drug marketing authorization holders or applicants must first register and authenticate with their real-names at the Online Service Hall of the NMPA website, enter the "My Certificates" section of the Online Service Hall, and view and download the corresponding electronic drug registration certificate. They can also log on to the NMPA APP to view and download the electronic registration certificates.

　　IV. The electronic drug registration certificate does not contain attachments such as the pharmaceutical manufacturing process, quality standards, package inserts, labels etc. The above-mentioned attachments will be pushed to the "My Certificates" section of the legal representative space at the Online Office Hall of the NMPA website in the form of electronic documents simultaneously with the electronic drug registration certificate, which will be delivered upon successful push. The drug marketing authorization holders or applicants can download the documents.

　　V. The drug marketing authorization holder or applicant should properly keep the account number of the Online Office Hall of the NMPA website, the electronic registration certificate and relevant attached electronic documents, etc.

　　VI. Questions related to the use of the electronic drug registration certificates can be found in the "Frequently Asked Questions about Electronic Certificates" section at the Online Service Hall of the NMPA website.