In order to strengthen the supervision and guidance on the registration of pharmaceutical and mechanical combination products, further encourage the listing of pharmaceutical and mechanical combination products with clinical value, and build a management model of pharmaceutical and mechanical combination products suitable for China's national conditions, the state drug administration takes the technical evaluation of pharmaceutical and mechanical combination products as a regulatory scientific research project, The guiding principles for the registration and review of pharmaceutical and mechanical combination products focusing on the role of medical devices and the guiding principles for the registration and review of qualitative, quantitative and in vitro release studies of drugs in pharmaceutical and mechanical combination products focusing on the role of medical devices are hereby issued.

It is hereby notified.

enclosure:

1. Guiding principles for registration and review of pharmaceutical and mechanical combination products focusing on the role of medical devices

2. Guiding principles for registration and review of qualitative, quantitative and in vitro release studies of drugs in combination products of medical devices

State Food and Drug Administration

January 11, 2022

Source: State Food and Drug Administration，https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220117145645132.html?GXMEUwefOdZn=1642932643189