2. Product Categories

Ingredients Regulation Overview for Ingredient Manufacturers
South Korea

This section provides the regulatory definition of the ingredients' categories in scope.

2.1 Pharmaceutical Product

New Drug: a drug of novel materials with new chemical structure or combination of substances, or a combination drug containing novel materials as active substance. Drugs listed in the Korean Pharmacopoeia or foreign pharmacopoeia recognized by the MFDS are excluded.

Pharmaceutical required for data submission refers not to a new drug, but a pharmaceutical that requires evaluation of safety and efficacy (e.g., new composition or increase/decrease in the strength of active drug substance, new route of administration, etc).

Generic drug: pharmaceutical that is equivalent to a reference drug in terms of active ingredient, dosage form, and strength.

2.2 Health Supplement

Health Functional Food: food that is manufactured or processed in order to supplement nutrients that may be deficient in the daily meal or to provide functional ingredients useful for the human body.

2.3 Veterinary Drugs

Veterinary Medicines refer to medicines intended for use only in animals, and include medicines for beekeeping, sericulture, fisheries and pets.

2.4 References

1. Pharmaceutical Affairs Act

https://elaw.klri.re.kr/eng_service/lawView.do?hseq=40196&lang=ENG

2. Rules for Handling Veterinary Medicines, etc. Enforcement 2024.1.5 [Ministry of Agriculture, Food and Rural Affairs Ordinance No. 628, 2024.1.5., partially revised]

https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EB%8F%99%EB%AC%BC%EC%9A%A9%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EC%B7%A8%EA%B8%89%EA%B7%9C%EC%B9%99 (In Korean)