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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 and management of services", optimize the business environment, further stimulate the development vitality of market players, and provide enterprises with more efficient and convenient government services, after research, it was decided to issue electronic registration certificates
for drugs from November 1, 2022.
The relevant matters are hereby announced as follows:
for drugs from November 1, 2022.
The relevant matters are hereby announced as follows:
1.
The scope of issuance of drug electronic registration certificate is from November 1, 2022, the certificate of drug clinical trial, drug marketing authorization, drug re-registration, drug supplement application, protection of traditional Chinese medicine species, imported medicinal materials, chemical raw materials and other certificates approved by the State Food and Drug Administration, as well as the certification certificate
of drug non-clinical research quality management norms.
The scope of issuance of drug electronic registration certificate is from November 1, 2022, the certificate of drug clinical trial, drug marketing authorization, drug re-registration, drug supplement application, protection of traditional Chinese medicine species, imported medicinal materials, chemical raw materials and other certificates approved by the State Food and Drug Administration, as well as the certification certificate
of drug non-clinical research quality management norms.
Second, the electronic registration certificate of drugs has the same legal effect
as the paper registration certificate.
Electronic certificates have functions
such as instant delivery, SMS reminder, license authorization, code scan query, online verification, and network-wide sharing.
as the paper registration certificate.
Electronic certificates have functions
such as instant delivery, SMS reminder, license authorization, code scan query, online verification, and network-wide sharing.
3.
The holder or applicant of the drug marketing authorization must first register in the online office hall of the State Food and Drug Administration and authenticate it with real name, enter the "My License" column of the online office hall, and view and download the corresponding drug electronic registration certificate
.
You can also log in to the "China Food and Drug Administration APP" to view the use of electronic registration certificate
.
The holder or applicant of the drug marketing authorization must first register in the online office hall of the State Food and Drug Administration and authenticate it with real name, enter the "My License" column of the online office hall, and view and download the corresponding drug electronic registration certificate
.
You can also log in to the "China Food and Drug Administration APP" to view the use of electronic registration certificate
.
Fourth, the drug electronic registration certificate does not contain drug production process, quality standards, instructions and labels and other accessories
.
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 electronic registration certificate of the drug, and the delivery is immediately upon successful push, and the drug marketing authorization holder or applicant can log in and download it
by himself.
.
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 electronic registration certificate of the drug, and the delivery is immediately upon successful push, and the drug marketing authorization holder or applicant can log in and download it
by himself.
5.
The holder or applicant of the drug marketing authorization shall properly keep the account number of the online office hall of the State Food and Drug Administration, the electronic registration certificate and the relevant electronic documents of the attachments
.
The holder or applicant of the drug marketing authorization shall properly keep the account number of the online office hall of the State Food and Drug Administration, the electronic registration certificate and the relevant electronic documents of the attachments
.
6.
For questions related to the use of drug electronic registration certificates, please refer to the "FAQs of Electronic Licenses" column
in the online office hall of the State Food and Drug Administration.
For questions related to the use of drug electronic registration certificates, please refer to the "FAQs of Electronic Licenses" column
in the online office hall of the State Food and Drug Administration.
This is hereby announced
.
.
State Food and Drug Administration
October 9, 2022