Notice on the Filling of Information on Drugs Related to the Ninth Batch of Centralized Purchasing of Drugs by State Organizations

Source: State-organized centralized procurement of medicines

Various pharmaceutical-related companies:

In order to do a good job for the ninth batch of state-organized centralized procurement of drugs, to further optimize the workflow, the establishment of a regular working mechanism, since August 28, 2023, the Joint Purchasing Office to carry out the ninth batch of state-organized centralized procurement of drugs related to drug information filling, is hereby notified of the relevant matters as follows:

I. Drug Requirements Listed drugs that belong to the scope of drug reporting (see Annex for details) and have obtained valid domestic registration approvals and meet one of the following requirements should have the corresponding approvals or can be queried in the State Drug Administration Drug Evaluation Center, "Chemical Drugs Catalog Set" in the corresponding results: 1. Reference preparations for consistency evaluation of the quality and efficacy of generic drugs issued by the state drug regulatory and supervision departments. 2. Generic drugs that have passed the consistency evaluation of quality and efficacy of generic drugs by the State Drug Administration and Supervision Department. 3. according to the Announcement of the State Food and Drug Administration on the Reform Work Program of Chemical Drug Registration Classification [No. 51 of 2016] or the Circular of the State Drug Administration on the Release of Chemical Drug Registration Classification and Requirements for Reporting Information [No. 44 of 2020], the generic drugs approved according to the registration classification of chemical drugs and proved to be consistent in terms of quality and therapeutic efficacy with the reference preparations.Enterprise Requirements The relevant enterprises that belong to the scope of this drug filing and meet the drug requirements include: domestic drug manufacturers providing drugs and accompanying services, holders of listed drug licenses, and domestic agents of overseas holders of listed drug licenses. The agent referred to above refers to the enterprise or legal person in China designated by the overseas holder of the certificate of registration of the drug in accordance with the regulations of the relevant state departments on the management of the domestic agent of the overseas holder of the marketing authorization of the drug to perform the obligations of the holder of the marketing authorization of the drug in accordance with the laws and regulations on behalf of the overseas holder of the certificate of registration of the drug in accordance with the laws and regulations of China.Third, fill in the content 1, the manufacturer, the drug marketing license holder, the overseas drug marketing license holder of the domestic agent of the supporting materials (including enterprise name, unified social credit code, contact person, authorization, etc.). 2、Certificates of compliance with drug requirements (including drug registration approvals, supplemental registration approvals, instructions, etc.). 3, production capacity and API self-production instructions. 4、Enterprise commissioned production, transfer of approvals, affiliation information.Notes 1, fill in the way: please log in the national health insurance information platform (URL: fuwu.nhsa.gov.cn, select "Drugs and Medical Consumables Procurement Services" - "State Organization of Centralized Purchasing of Drugs Information Filing "-"Enterprise Login") to fill in new users need to click "Register" on the login page, and fill in the relevant information as required to complete the registration of the platform account; if you have a platform account, you need to re-submit the information related to this centralized procurement. Need to re-submit the qualification documents related to the collection and procurement, to be reviewed and approved before the "variety of information" maintenance. The user account is valid for a long time without repeated registration. 2、Audited drug information confirmed by the enterprise will generate the "Declaration Information List", as the basis for the declaration of the ninth batch of state-organized centralized purchasing of medicines, please fill in the relevant information correctly. Please fill in the relevant information correctly. Specific requirements are subject to the provisions of the procurement documents. 3、Contact: 021-31773244, 31773255, 31773266 (Service hours 8:30-11:30, 13:30-16:30, except holidays) Notice is hereby given.

Joint Procurement Office August 28, 2023