Notice on Regulating Administrative License Items of Health Food (National Food & Drug Administration, No. 321 [2011])

The food and drug supervision authorities (drugs supervision bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government, relevant units:

In order to regulate and strengthen the management of health food administrative licenses, according to the relevant provisions of the “Measures for the Administration of Registration of Health Food Products (Trial)”, the following notice on the relevant administrative licenses for health foods is as follows:

1. In the process of registration of health food products, where supplementary materials are required, the time limit for submitting supplementary materials is 5 months. If it cannot be submitted on time due to special circumstances, it may be prolonged to one year according to the procedure. When the applicant submits additional information, it shall provide relevant information.

2. Domestically-produced health foods that have been applied for re-registration have not been produced or sold within the five-year validity period of the approval certificate. Sample production, on-site inspections, inspections, and technical evaluations shall be carried out in accordance with relevant regulations and procedures. If the product has been produced and sold within the five-year validity period of the approval certificate, the product quality inspection report issued by the registered inspection agency determined by the State Food and Drug Administration shall be provided when applying for re-registration.

Third, the same applicant for the declaration of the same raw materials and main materials, dosage forms of different products, the applicant should provide different types of formulations for scientific and reasonable basis.

4. For health foods with the same raw materials and major excipients, different tastes or colors, such as safety toxicology evaluation tests and functional evaluation tests, which are not registered at the time of registration of new products, applicants should make up for the registration of technology transfer products. The two types of tests.

5. When applying for technology transfer to register a product or change a product name, the applicant shall provide a commitment letter of no violation of laws and regulations within 2 years.

This notice will come into effect on September 1, 2011. If the relevant provisions previously issued are inconsistent with the provisions of this notice, the provisions of this notice shall prevail.

State Food and Drug Administration July 21, 2011