식품의약품안전처 (Ministry of Food and Drug Safety)

식품의약품안전처 (Ministry of Food and Drug Safety, MFDS) regulates food, medicines, medical devices and biological products in the Republic of Korea. In regenerative medicine it sits on the product and facility side of the split with the Ministry of Health and Welfare: MOHW designates the institution that treats patients, MFDS permits the facility that handles the cells.

A 첨단재생의료세포처리시설 (advanced regenerative medicine cell processing facility) must hold an MFDS permit before it may collect, test, process and supply human cells to a regenerative medicine institution. Permitted facilities are listed publicly with their representative and permit date, so a claim to hold one can be checked against the register rather than taken on trust.

MFDS also authorises advanced biological products themselves. Minimal manipulation of a patient's own cells within a permitted facility and an approved plan is a different regulatory route from marketing a cell therapy product, and the two are frequently conflated in marketing material.