Provinces, autonomous regions, municipalities directly under the central government, and the Drug Administration of Xinjiang Production and Construction Corps: In order to implement the requirements of the Drug Administration Law, the Measures for the Administration of Drug Registration, and the Measures for the Supervision and Administration of Drug Production, and further guide drug marketing authorization holders (hereinafter referred to as holders) to establish an annual reporting system, the National Medical Products Administration has organized the formulation of the "Regulations on the Administration of Drug Annual Reports" (see Annex 1) and the "Template for Drug Annual Reports" (see Annex 2), which are now issued. At the same time, in order to ensure the implementation of the annual drug reporting system, the National Medical Products Administration has built a drug annual report collection module, which will be put into use at the same time. The relevant matters are hereby notified as follows: 1、 Urge holders to fulfill their main responsibility for the annual drug report The annual drug reporting system is a new system proposed by the Drug Administration Law. The Drug Administration Law clearly stipulates that the holder of a drug marketing authorization shall establish an annual reporting system, and report the production and sales, post marketing research, risk management, and other information of the drug to the drug regulatory department of the provincial, autonomous region, and municipality directly under the Central Government in accordance with regulations every year. The entity responsible for submitting the annual report is the holder; If the holder is an overseas enterprise, the enterprise legal person designated by it in accordance with the law and bearing joint and several liability within China shall fulfill the annual reporting obligation. Provincial drug regulatory departments should strengthen policy promotion and supervision guidance, and further urge holders to fulfill their main responsibility for quality management throughout the entire process by standardizing their annual reporting behavior. Holders should take the annual report as a starting point, enhance their sense of main responsibility, exert subjective initiative, and further improve their own management level. The holder shall designate a dedicated person to be responsible for the annual report work, improve the internal report management system, strictly review and control the content of the annual report, and ensure that the information filled in is true, accurate, complete, and traceable. 2、 Effectively carry out data sharing and information application The National Medical Products Administration has established a drug annual report collection module. For the convenience of holders to fill in, this module directly connects with the drug registration, drug production license and other relevant information of the drug regulatory data sharing platform, realizing the automatic retrieval of key basic information, which helps to improve the accuracy of filling in information. In the future, we will fully leverage the advantages of the national drug regulatory data sharing platform and gradually collect annual report information into drug variety archives and drug safety credit archives, consolidating the information foundation of intelligent drug supervision. Provincial drug regulatory departments should use annual report information as reference materials and judgment basis for supervision and inspection, risk assessment, credit supervision, and other work, gradually achieving precise and scientific supervision, and improving the efficiency of drug lifecycle supervision. At the same time, in conjunction with work arrangements such as supervision and inspection, the content of the annual report of the holder shall be reviewed, and holders who do not comply with the regulations in the annual report shall be investigated and punished in accordance with the law, and included in the drug safety credit file.
3、 Make every effort to operate and maintain the annual report collection module The drug annual report collection module is divided into enterprise end and regulatory end. The collection of information on the enterprise side includes two aspects: the public part and the product part. Among them, the public part includes six aspects: holder information, overall situation of held products, overview of quality management, construction and operation of drug surveillance system, acceptance of overseas commissioned processing, and acceptance of inspection by overseas drug regulatory agencies; The product section includes four aspects: product basic information, production and sales situation, post market research and change management situation, and risk management situation. After the holder completes the filling and submission of the drug annual report, the provincial drug regulatory department can view the drug annual report information of the holder within its administrative region through the regulatory end. The Information Center of the National Medical Products Administration should provide technical support after the module is launched. The permission opening and operation procedures for the enterprise and regulatory ends can refer to the operation manual (see Appendix 3 and Appendix 4). The latest electronic version of the operation manual can be downloaded from the system. If any problems are found during the use of the system, users can contact the technical support customer service hotline at any time (4006676909 ext. 2); You can also communicate and stay in touch by joining the QQ working group (supervised user: 320404770; enterprise user: 282253676). 4、 Other matters 1. This regulation shall come into effect from the date of publication, and the drug annual report collection module shall be simultaneously activated. Considering that China has implemented the drug annual report system for the first time, 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, submit the previous year's report information before April 30th every year. Attachment: 1. Regulations on the Management of Annual Drug Reports 2. Template for Drug Annual Report Management Regulations (2022 Edition) 3. Annual Drug Report Collection Module Enterprise Operating Manual 4. Operation Manual for Regulatory End of Drug Annual Report Collection Module