Pharmaceuticals

What Are Quasi-Drugs?

Quasi-drugs are products designated by the Minister of Food and Drug Safety that fall into one of the categories below. Products used for the purposes in Article 2(4)(b) and (c) of the Pharmaceutical Affairs Act are excluded. (Pharmaceutical Affairs Act, Article 2(7))

• Textile or rubber products, or similar items, used to treat, relieve, manage, or prevent disease in humans or animals
• Items that act only mildly on the human body or do not act on it directly and are not instruments or machines, and similar items
• Preparations used for disinfection, insect control, or similar purposes to prevent infectious diseases

Scope of Quasi-Drugs (for details, see the MFDS notice "Designation of the Scope of Quasi-Drugs")

Product Approval for Pharmaceuticals, etc.

To obtain product approval, submit an application (Annex Form No. 4, electronic form accepted) with the documents below (electronic documents accepted) to the Minister of Food and Drug Safety.

Required Documents

• Safety and efficacy data (not required for products listed in the Korean Pharmacopoeia, etc.)
• Data on specifications and test methods
• Data from bioequivalence studies or comparative clinical trials (applicable prescription drugs only)
• Certificate of manufacture and certificate of free sale for the imported product (issued by a government or public agency of the country of manufacture or approval)
• Data needed to assess compliance with Good Manufacturing Practice (GMP) for pharmaceuticals
• Data on the name, location, and other details of the manufacturer of the active pharmaceutical ingredient
• Where applicable: risk management plan, patent status confirmation, etc.

Data that received a notice of conformity in a prior review may be replaced by that notice. For details, see Article 4 of the Regulations on Safety of Pharmaceuticals, etc.

Products Eligible for Product Notification

The products below are subject to product notification rather than approval. Excluded are products that require safety and efficacy data, drugs applied for on the basis of a listed drug's safety and efficacy data, products for which manufacturing/marketing or import approval and notification are restricted, biologics, etc., and radiopharmaceuticals.

• Products listed in the Korean Pharmacopoeia or in official compendia and formularies recognized by the Minister of Food and Drug Safety (excluding products not approved in Korea)
• Products listed in the Korean Herbal Pharmacopoeia
• Products that meet the standard manufacturing criteria published by the Minister of Food and Drug Safety, which standardize ingredient type, specifications, strength, formulation, and the like
• Products for which the Minister of Food and Drug Safety has published separate specifications and test methods
• Pharmaceuticals, etc. designated by the Minister of Food and Drug Safety as subject to notification

Product Notification Procedure for Pharmaceuticals, etc.

To file a product notification, submit a manufacturing/marketing or import product notification form (Annex Form No. 6, electronic form accepted) with the materials below to the head of the competent Regional Office of Food and Drug Safety.

• Data showing that the product qualifies for notification
• Data on specifications and test methods (only for standard-manufacturing-criteria products not yet found GMP-compliant and for products designated as subject to notification)
• Data on drug equivalence (only for drugs for which the Minister of Food and Drug Safety requires proof of equivalence)
• Certificate of manufacture and certificate of free sale for the imported product (may be omitted if the criteria published by the Minister of Food and Drug Safety are met)
• Data needed to assess compliance with Good Manufacturing Practice (GMP) for pharmaceuticals
• Where applicable: data on drug substances, the active ingredient manufacturer, and contract manufacturing

For details, see Article 5 of the Regulations on Safety of Pharmaceuticals, etc.

Import Process for Pharmaceuticals and Quasi-Drugs

1. Importer notification + product approval (notification)
2. Standard Pre-Clearance Report filed and issued
3. Import declaration certificate issued
4. Customs clearance
5. Quality testing
6. Passed
7. Sale

BSE (Bovine Spongiform Encephalopathy) Document Requirements

Among pharmaceuticals, etc. that contain or use materials derived from ruminants such as cattle, sheep, or goats, products derived from specified risk materials of EU origin and products that contain or use bovine-derived materials (except gelatin) from the United Kingdom or Northern Ireland may not be imported. For all other products, submit documents according to the criteria below. (Consolidated Public Notice on Import and Export (Tonghap Gonggo), Article 35(12))