,2 min read
Understanding the classification of drugs in South Korea is essential for companies planning market entry, as it directly impacts Regulatory pathways, dossier requirements, and approval timelines. The system is governed by the Ministry of Food and Drug Safety (MFDS) under the Pharmaceutical Affairs Act and forms a key part of broader South Korea pharmaceutical regulations.
Main Categories
- Drug Products vs. Drug Substance
- Drug Products are formulations intended for therapeutic use.
- Drug Substance (or Active Pharmaceutical Ingredients, APIs) refers to the active ingredient responsible for the pharmacological effect of the drug product.
They are regulated separately under MFDS drug classification South Korea guidelines.
Classification of Drug Products
In South Korea, drug approval pathways are commonly grouped into three categories for regulatory review purposes:
- New Drugs- Innovative compounds with entirely new chemical structures or compositions, or novel combination preparations.
- Pharmaceuticals Requiring Data Submission- Products that are not new drugs but require partial data due to changes such as indication, dosage, formulation, or route of administration.
- Generic Drugs- Products equivalent to a reference drug in terms of active ingredient, strength, and dosage form, requiring demonstration of bioequivalence and quality data.
Special Categories to Be Aware Of
- Prescription Drugs vs. OTC Drugs
- Prescription Drugs require a prescription from a licensed physician and are dispensed through pharmacies.
- Over the Counter (OTC) Drugs are accessible without a prescription, though some “Safety OTC” medicines may be sold in designated retail outlets such as convenience stores under strict regulatory control.
- Quasi-Drug Products
- This category includes low-risk products regulated under the Pharmaceutical Affairs Act, including items such as masks, bandages, and insect repellents. Depending on the product type, quasi-drugs require either product approval or notification prior to manufacture or import.
Summary Table: Classification Overview
| Classification Type | Description |
|---|---|
| New Drug | Products containing new active ingredients or new combinations requiring full safety and efficacy data |
| Pharmaceuticals Requiring Data | Products requiring partial data due to changes such as indication, dosage, formulation, or route of administration |
| Generic Drug | Equivalent to a reference drug; requires demonstration of bioequivalence and quality data |
| Prescription vs. OTC | Prescription drugs require a physician’s prescription; OTC drugs are available without prescription |
| Quasi-Drug Products | Low-risk items products such as masks, bandages, and insect repellents regulated under the Pharmaceutical Affairs Act |
Final Thoughts
A clear understanding of the classification of drugs in South Korea enables companies to select appropriate approval strategies, prepare accurate dossiers, and avoid unnecessary delays. Aligning with South Korea pharmaceutical regulations and the MFDS drug classification South Korea framework ensures smoother approvals and more efficient market entry.
If you'd like personalized assistance from classification reviews to dossier preparation and MFDS liaison support contact Freyr, our experts specialize in South Korean pharmaceutical registration and compliance.