Notice of the State Food and Drug Administration on Printing and Distributing the "Regulations on the Administration of Drug Annual Reports"

Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps:
In order to implement the relevant requirements of the "Drug Administration Law", "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production", and to further guide the holders of drug marketing authorizations (hereinafter referred to as holders) to establish an annual reporting system, the National Medical Products Administration The Bureau organized the formulation of the "Regulations on the Administration of Drug Annual Reports" (see Annex 1) and the "Template of Drug Annual Reports" (see Annex 2), which are hereby issued. At the same time, in order to ensure the implementation of the drug annual report system, the State Food and Drug Administration has built a drug annual report collection module, which will be activated at the same time. The relevant matters are hereby notified as follows:
1. Urge the holder to implement the main responsibility of the annual drug report
The annual drug report system is a new system proposed by the Drug Administration Law. The "Drug Administration Law" clearly stipulates that drug marketing license holders shall establish an annual reporting system, and report the production and sales, post-marketing research, risk management, etc. of drugs to the drug regulatory department of the people's government of the province, autonomous region, and municipality directly under the Central Government every year. The holder of the annual report shall be the holder; if the holder is an overseas enterprise, the legal person of the enterprise that is legally authorized and bears joint and several liability within the territory of China shall perform the obligation of the annual report.
Provincial drug regulatory authorities should strengthen policy publicity, supervision and guidance, and further urge holders to implement the main responsibility for quality management throughout the process by regulating holders' annual reporting behavior. Holders should take the annual report as a starting point to enhance their awareness of subject responsibility, give full play to their subjective initiative, and further improve their own management level. The holder shall appoint a special person to be responsible for the annual report, improve the internal report management system, strictly review and check the content of the annual report, and ensure that the information filled in is true, accurate, complete and traceable.
2. Effectively do a good job in data sharing and information application
The State Food and Drug Administration has built a drug annual report collection module. In order to facilitate the holder to fill in the report, this module directly connects to the drug registration, drug production license and other relevant information of the drug regulatory data sharing platform, and realizes the automatic transmission of key basic information, which helps to improve the accuracy of the filling information. In the follow-up, it will give full play to the advantages of the national drug supervision data sharing platform, and gradually collect the annual report information into the drug variety file and drug ** credit file respectively, and consolidate the information foundation for smart drug supervision.
All provincial drug regulatory authorities should use the annual report information as a reference material and research basis for supervision and inspection, risk assessment, credit supervision and other work, and gradually realize comprehensive and scientific supervision, and improve the supervision efficiency of the whole life cycle of drugs. At the same time, in combination with supervision and inspection and other work arrangements, the content of the holder's annual report will be reviewed, and the holder who does not submit the annual report as required will be investigated and punished according to law, and it will be included in the drug ** credit file.
3. Make every effort to do a good job in the operation and maintenance of the annual report collection moduleThe drug annual report collection module is divided into the enterprise side and the regulatory side. The information collected by the enterprise includes two aspects: the public part and the product part. Among them, the public part includes the information of the holder, the overall situation of the products held, the overview of quality management, the construction and operation of the pharmacovigilance system, the acceptance of overseas commissioned processing, and the acceptance of inspections by overseas drug regulatory agencies; the product part includes Product basic information, production and sales, post-market research and change management, and risk management. After the holder completes and submits the annual drug report, the provincial drug regulatory department can view the information of the holder's annual drug report within the administrative area through the regulatory terminal.
The information center of the State Food and Drug Administration should do a good job in technical support after the module goes online. Please refer to the operation manual (see appendix 3 and appendix 4) for the authorization and operation procedures of the enterprise side and the supervisor side. **New electronic version of the operation manual can be downloaded from the system. If problems are found during the use of the system, users can contact the technical support customer service hotline (4006676909 to 2) at any time; they can also communicate by joining the QQ work group (supervisory users: 320404770; enterprise users: 282253676).
4. Other matters
1. These regulations will come into force from the date of promulgation, and the drug annual report collection module will be activated at the same time.
2. In view of the implementation of the annual drug report system in my country, the drug annual report collection module is still in the trial operation stage, and the deadline for filling in the 2021 annual report information is August 31, 2022; starting from next year, fill in the report before April 30 every year Annual report information.
Annex: 1. Regulations on the Administration of Annual Reports of Drugs
2. Template for the Administration of Drug Annual Reports (2022 Edition)
3. Enterprise-side operation manual of drug annual report collection module
4. Operation Manual for the Supervisory Terminal of the Collection Module of the Drug Annual Report
State Food and Drug Administration