From November 1, the electronic registration certificate for drugs will be issued, which has the same legal effect as the paper registration certificate

Announcement of the State Food and Drug Administration on the Issuance of Electronic Registration Certificates for Drugs (No.
83 of 2022)

In order to implement the important decision-making and deployment of the Party Central Committee and the State Council on deepening the reform of "decentralization, management and service", optimize the business environment, further stimulate the vitality of the development of market entities, and provide enterprises with more efficient and convenient government services, it has been decided after research that from November 1, 2022, the electronic registration certificate
for drugs will be issued.
The relevant matters are hereby announced as follows:

1.
The scope of issuance of electronic drug registration certificates is from November 1, 2022, and certificates of drug clinical trials, drug marketing authorization, drug re-registration, drug supplement application, protection of traditional Chinese medicine varieties, imported medicinal materials, chemical APIs, etc.
, as well as certificates of drug non-clinical research quality management practices approved by the State Food and Drug Administration
.

2.
The electronic registration certificate for drugs has the same legal effect
as the paper registration certificate.
Electronic licenses have functions
such as instant delivery, SMS reminder, license authorization, code scanning query, online verification, and network-wide sharing.

3.
The drug marketing authorization holder or applicant must first register in the online office hall of the State Food and Drug Administration and authenticate their real names, enter the "My Licenses" column of the online office hall, and view and download the corresponding electronic registration certificate
for drugs.
You can also log in to the "China Food and Drug Administration APP" to view the use of electronic registration certificates
.

4.
The electronic registration certificate for drugs does not contain accessories
such as drug production process, quality standards, instructions and labels.
The above-mentioned attachments are simultaneously pushed to the "My License" column of the legal person space of the online office hall of the State Food and Drug Administration in the form of electronic documents and the drug electronic registration certificate, and the push will be delivered immediately, and the drug marketing authorization holder or applicant can log in and download it by
themselves.

5.
Drug marketing authorization holders or applicants shall properly keep the account number, electronic registration certificate and related attachments and electronic documents of
the NMPA.

6.
For questions related to the use of electronic drug registration certificates, please refer to the "FAQs on Electronic Licenses" column in the online office hall of the State Food and Drug Administration
.

This is hereby announced
.

NMPA