The National Allied Procurement Office has released a notification initiating the information filing process for drugs selected in the 10th national volume-based procurement (VBP) tender round. This marks another step in China’s ongoing efforts to streamline drug procurement and ensure accessibility.
Information Filing Process and Requirements
Enterprises are required to log in to fuwu.nhsa.gov.cn to complete the information filing form. The form includes several key components:
① Proof materials of the manufacturers, drug marketing authorization holder (MAH), and domestic agent of the overseas drug MAH, which should include enterprise name, unified social credit code, contact person, and authorization letter;
② Proof materials that meet the requirements of the drug, including drug registration approval, supplementary registration approval, and instructions;
③ Description of production capacity and self-produced raw materials;
④ Information on entrusted production by enterprises, transfer of approval documents, and related relationship details.
Scope of Eligible Enterprises
The relevant enterprises that are within the scope of this drug application and meet the drug requirements include domestic drug manufacturers providing drugs and accompanying services, drug marketing authorization holders, and domestic agents of overseas drug MAHs. The term ‘agent’ refers to a Chinese enterprise legal person designated by the overseas holder who has obtained the drug registration certificate in accordance with the relevant national department’s regulations on the management of domestic agents of overseas drug marketing authorization holders. These agents represent the overseas holders in fulfilling the obligations of drug MAHs as stipulated by laws and regulations.- Flcube.com
