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Question:

FDA在中国成立办公室,在中国有哪些职责?是否会进行核查?


Answer:

具体可以参见FDA 网站对中国office的介绍

网址:https://www.fda.gov/about-fda/office-international-programs/china-office

FDA China office mission在官网有详细介绍,主要包括:

The mission of FDA’s China Office is to strengthen the safety, quality, and effectiveness of food and medical products produced in China for export to the United States. FDA’s China Office works to fulfill this mission through:

Conducting inspections at facilities that manufacture FDA-regulated goods

Collaboration, capacity-building and confidence-building with Chinese regulatory counterparts, at the central, provincial, and municipal level

Outreach to regulated Chinese firms that wish to export their products to the United States to enhance understanding of FDA standards

Monitoring and reporting on conditions, trends and events that could affect the safety, quality, and effectiveness of FDA-regulated products exported to the United States

FDA 在中国的office承担核查工作,目前来看是以GMP为多,但是也会根据总部安排配合总部进行GCP核查等。