On November 16, 2021, SAMR released for comment draft regulations entitled “General Rules for Food Manufacturing License Review (2021)” (the “2021 Draft” or the “Draft”). The 2021 Draft sets forth the license review scheme for food varieties that are difficult to classify, such as new food raw materials or foods in new forms that emerge in the future, and when an amendment to the food manufacturing license must be submitted (e.g., changes in main production equipment). The 2021 Draft also describes situations that can be exempted from on-site manufacturing inspections, including when the manufacturing process information was reviewed during a special food registration approval process (e.g., health foods, infant formula products, and foods for special medical purposes), and when the application is for a license renewal and there have been no changes to the manufacturing conditions since initial registration or last renewal. The Draft authorizes regulators to re-inspect a facility when there is a major change in national food safety standards.

The 2021 Draft appears intended to make the license review process more efficient by shortening timeframes for inspection and for a company’s rectification of any issues identified during the inspection. Specifically, the Draft shortens the time limit: (1) for the inspection team to complete its on-site inspection from 10 business days to 5 business days; (2) to dispute the inspection process and findings from 3 business days to 1 business day; and (3) for rectification of issues identified during the inspection (if the company otherwise passes the inspection) from one month to 20 business days. The Draft also describes the personnel that should compose the inspection team and their responsibilities.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Annie Wang, and Kaixin Fan