China Health Foods: CFDA Consults on Health Food Production Licensing Examination

Takehome:

• The requirements on health food production licensing examination have been proposed, including paper review, field inspection, and licensing examination.

On May 19, 2016, China Food and Drug Administration (CFDA) preannounced the “Examination Details of Health Food Production Licensing”, which will be open for public consultation until Jun. 1, 2016.

This regulation is applicable to the examination of domestic health food production licensing, including paper review, field inspection, and licensing examination.

Paper review:

Paper review includes the examination of qualification documents, production condition documents, and OEM production documents.

OEM production is allowed for health foods required for filing. However, the consigner should be the holder of health food approval certificate, and the consignee should be provided with qualifications and the corresponding production condition for producing health food of the same dosage.

Field inspection:

Field inspection includes production condition inspection, quality management examination, and production process examination. 82 inspection items in total are included in field inspection.

Licensing examination:

Sampling inspection of trial products should be carried out after paper review and field inspection. The samples will be delivered to certified testing agencies for full item inspection, and reexamination will be carried out after that according to the technical requirements of health food registration or filing as well as the enterprise standard of the product.

Reference link

CFDA No. 116 (2016) Announcement