1. How to manage infant formula for special medical purposes?

China implements strict supervision and management of infant formulas for special medical purposes mainly in accordance with the Food Safety Law. First of all, as long as it is produced, sold and imported in China, it should be registered by the food safety supervision and administration department of the State Council (ie, the State Administration for Market Regulation). To apply for the registration of foods for special medical purposes, the application documents shall be submitted to the national competent authority, and the applicant shall be responsible for the authenticity of the application documents. The review agency reviews the application documents. The verification agency conducts on-site verification of the applicant’s research and development capabilities, production capabilities, and inspection capabilities. The review agency entrusts a food inspection agency with statutory qualifications to conduct sampling inspections. The verification agency conducts on-site verification of authenticity, completeness, accuracy of clinical trials. After obtaining the product registration certificate, the enterprise that intends to produce and sell special medical food in China shall also apply for the production license of infant food for special medical purposes in accordance with the conditions and procedures stipulated in the Examination Rules for the Production Licensing of Food for Special Medical Purposes. The food safety supervision and administration departments of the provinces (that is, the market supervision administrations of the provinces, municipalities directly under the Central Government, or autonomous regions) conduct production license inspections on enterprises. Only after the enterprise passes the review, the provincial market supervision and management department will issue a production license for the category of products, then the enterprise can produce and sell.

2. Currently registered infant formula for special medical purposes

According to the List of Approved and Registered Food for Special Medical Purposes published on the website of the State Administration for Market Regulation, as of the end of February 2021, 31 formulas have passed the registration and approval of infant formulas for special medical purposes, including 6 lactose-free formulas. 6 partially hydrolyzed milk protein formulas, 4 deep hydrolyzed milk protein or amino acid formulas, 11 premature/low birth weight infant formulas, 3 infant food supplements, and 1 amino acid metabolism disorder formula.

More information on infant formula for special medical purposes, please click Common Sense about Infant Formula for Special Medical Purposes I.