Quasi-drug is a special part of Korean consumer goods. Toothpastes, deodorant and many other personal care products are cosmetics in China, the U.S, and other countries, though, they belong to quasi-drug in South Korea.
Different from cosmetics, premarket review is required for quasi-drug products. Enterprises must obtain a product permission or notification from the Ministry of Food and Drug Safety (MFDS) for the product before importation or distribution. Therefore, product compliance is significant for enterprises targeting the Korean market.
Note, that cosmentics with efficacies such as sun blocks, anti-aging creams, are defined as functional cosmetics in South Korea.
Chapter 1. Regulatory Framework and Competent Authority
1.1 Existing Main Quasi-Drug Regulations in South Korea
The regulations related to the quasi-drug industry in South Korea are:
The Korean authority also issued guidelines to help enterprises better conduct quasi-drug business. The guidelines include:
1.2 Competent Authority
In South Korea, MFDS takes the overall management of quasi-drugs, including standard establishment, product licensing, business registration, etc.
Korea Pharmaceutical Traders Association (KPTA), although not a governmental organization, is also an important regulatory organizations for quasi-drug in South Korea. Each time before export, the enterprise should submit an "entry notice of imported products (표준통관 예정보고)" to KPTA. KPTA will pre-evaluate the products and issue approval to the compliant products.
Chapter 2. Quasi-Drug Products
2.1. Definition of Quasi-Drug Products
According to the Pharmaceutical Affairs Act, the term "quasi-drug (의약외품)" refers to any of the following:
(a) Fibers, rubber products, or similar products used for treatment, alleviation, care, or prevention of human or animal diseases;
(b) Non-appliance, non-machinery, or similar articles that have insignificant influences on or do not directly act upon human bodies;
(c) Preparations for sterilization, insecticide, and other similar uses to prevent infectious diseases.
2.2. Classification of Quasi-Drug Products
Quasi-drugs can be divided into three groups parts according to the above-mentioned definition. And the Designation of Quasi-Drug Scope further details the specific items:
a | Sanitary products (menstrual pads, tampons, and menstrual cups), Masks (surgical, medical, and respiratory masks), Materials for wound preservation, protection, and treatment (eye patches, bandages, gauze, degreasing cotton, splints, etc.) |
b | Oral antiseptics, Antiperspirants, Toothpaste, Prickly heat and impetigo medicines, Mosquito repellents, Contact lens care products, Smoking cessation aids/Smoking habit improvement aids, Topical disinfectants, Ointment, Cataplasma, Spray for pain relief, Low-dose vitamin and mineral preparations, Nutrient tonics (liquid), Digestants (liquid) and antidiarrheals (solid), Root canal cleanser and disinfectant, Topical solution or acid solution for correcting thumb sucking habits of infants and young children, Snoring reducing agent, Tooth whitening agent, Denture and orthodontic appliance disinfectant, Tooth/gingival staining agent for diagnostic purposes |
c | Non-adhesive pads or sponges for wound exudate absorption, Sterilized cotton swabs, Sterilized gloves, Wet tissues for oral hygiene, Tooth manicure, Portable oxygen, Maternity pads |
2.3. General Safety Requirements for Quasi-Drugs
2.3.1. Permission and notification for quasi-drug
Permission and notification are important for quasi-drugs. Enterprises intending to import to or sell quasi-drugs in South Korea, must obtain a permission or notification from MFDS before conducting the quasi-drug business.
Products subject to notification and permission are as below:
Quasi-drugs subject to notification (Enterprises need to apply for the notification to the Regional Food and Drug Administration） |
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Quasi-drugs subject to permission (Enterprises need to apply for the permission to MFDS) |
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Quasi-drugs subject to permission (Enterprises need to apply for permission to the Regional Food and Drug Administration） |
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To apply for the quasi-drug permission or notification, enterprises shall submit an application letter along with the following documents:
Documents for notification application | (1) Documents that can prove the product is subject to notification (2) Data on standards and testing methods |
Documents for permission application | (1) Safety and efficacy data (for product subject to safety and efficacy evaluation): 1) Information on the origin, discovery, and development 2) Data related to standards and testing methods 3) Data related to stability (long-term preservation test data or accelerated test data) 4) Data related to toxicity a. Single dose toxicity test data b. Repeated dose toxicity test data c. Reproductive and developmental toxicity test data d. Genotoxicity test data e. Immunotoxicity test data (including skin sensitization test data) f. Carcinogenicity test data g. Local toxicity test data 5) Data that can demonstrate the product’s efficacy and effect 6) Data on usage status in foreign countries 7) Data related to other characteristics, including comparative review with similar domestic products (2) Standards and testing methods data: 1) Information on origin, discovery, and development 2) Data related to structural determination, physicochemical properties, and biological properties (quality data) a. Data related to raw materials b. Data related to finished products 3) Data on foreign usage status 4) Data related to comparative review with similar domestic products and characteristic |
Documents for both situations |
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MFDS will review the docusments and officially publish the result. The permitted or declared quasi-drugs can be found via the Korean pharmacy online portal here. The review period may vary for different products, ranging from 10 to 70 days.
2.3.2. Product standards
The standards for each quasi-drug product are specified under the Manufacturing Standard of Quasi-Drug. This regulation details the effective ingredients, ingredient’s specifications and maximum amounts in the product, product’s efficacy, product daily intakes, precautions for use, storage method, and expiration date.
2.3.3. Tar coloring
The Designation, Standard and Test Methods of Tar Coloring for Quasi-Drugs outlines the tar pigments can be used both in medicines and quasi-drugs, including the scope and standards for:
Tar coloring for internal use;
Tar coloring for external use including mucous membranes;
Tar coloring for external use excluding mucous membranes;
Color lakes.
Besides, according to the regulation, the tar coloring used in quasi-drugs for internal use should be 0.1% or less of the total raw materials. In addition, for liquid internal preparations, the tar coloring should not exceed the specified daily allowable amount.
2.3.4. Label requirements
The manufacturers and importers shall include the following items on the containers or packaging of quasi-drugs:
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2.4. Registration for Quasi-Drug Manufacture and Import Business
Enterprises intending to manufacture or import quasi-drugs to South Korea shall apply for business registration with the Medical Safety Management Division of the relevant Regional Food and Drug Administration.
Dossiers for quasi-drug manufacture business registration include:
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Dossiers for quasi-drug import business registration include:
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Chapter 3. Export Procedure
As mentioned above, only enterprises that have finished the import business registration can import quasi-drugs to South Korea. Besides, the importer also needs to have:
Facilities: Business place and warehouse, testing laboratory (can be commissioned to a quality inspection agency)
Personnel: At least one import manager and one safety management officer
Product permission (or notification): at least one quasi-drug permission (or notification).
For each import, the importer should apply for an “entry notice of imported products (표준통관 예정보고)" to KPTA. After getting confirmation of compliance from KPTA, the customs clearance can be proceeded.
(Procedure of Quasi-drug Import, Click to zoom in)
Dossiers for import notification are:
For the first-time import: Business registration certificate Registration certificate for quasi-drug import business Quasi-drug permission (or notification) certificate Quasi-drug product manufacture business approval or quality inspection outsourcing contract BSE-related documents (if applicable) CITES-related documents (if applicable) Invoice and packing list Notification letter from MFDS regarding the overseas manufacturing plant registration of the relevant product manufacturer |
For repeated imports: Copy of the quasi-drug permission (or notification) certificate in case of changes in matters related to import business or product Trade documents (if necessary) BSE-related documents (if applicable) CITES-related documents (if applicable) Documents confirming that the imported product is compliant, such like initial inspection results report (to be submitted only for the first inspection). |
Chapter 4. Standards for Hot Products
4.1 Tooth Paste
Toothpastes refer to products intended to whiten and strengthen teeth, provide oral hygiene, and prevent diseases of the teeth, gums, and oral cavity. They can be made in the forms of pastes, liquids, gels, and acids.
Effective substances used in toothpastes include:
Item | Substances | Usage Limits or Concentrations (%) |
I | Sodium Monofluorophosphate Sodium Fluoride Stannous Fluoride N,N,N'-tris-(2-hydroxyethyl)-N'-octadecyl-1,3-diaminopropane dihydrofluoride | 0.76 0.22 0.4 1.31 (Total amount of fluorides shall be less than 1,000ppm) |
II | Calcium glycerophosphate | 0.13 |
III | Sodium Chloride Tocopherol Acetate Pyridoxin Hydrochloride Allantoin Aluminium Chlorohydroxy Allantoinate Tranexamic Acid Aminocaproic Acid | 0.5 ~ 10.0 0.01 ~ 1.0 0.02 ~ 0.06 0.01 ~ 2.0 0.001 ~ 0.3 0.05 0.001 ~ 0.2 |
IV | Sodium Pyrophosphate | 0.1 ~ 3.4 |
V | Dibasic Calcium Phosphated·2H2O Dibasic Calcium Phosphate Precipitated Calcium Carbonate Calcium Carbonate Tribasic Calcium Phosphate Colloidal Silicon Dioxide Silicon Dioxide Calcium Phosphate Hydrated silicon dioxide Dental type silica | 48.0 15.0 42.0 50.0 32.0 15.0 20.0 31.0 19.0 20.0 |
*If Precipitated Calcium Carbonate and Calcium Carbonate are formulated together, the total amount shall not exceed 65.0%.
General efficacies of toothpastes are "keeping tooth white and strong; keeping mouth clean; freshening breath; preventing tooth decay and eliminating bad breath; and enhancing beautification”. For toothpastes with special efficacies such as "prevention of gingivitis, periodontitis, periodontal disease, and gum disease”, they shall include at least one effective substance as listed below:
Prevention of gingivitis and periodontitis, Prevention of periodontal disease, Prevention of gum disease | Effective substances listed in Item III |
Preventing tartar build-up | Effective substances listed in Item Ⅳ |
Remove plaque | Effective substances listed in ItemⅤ |
4.2 Tooth whitener
Tooth whitener refers to gel products applied to tooth to whiten them. Hydrogen peroxide water is the only effective substance used in tooth whitener, with an amount of 35% or 8.57g/100g.
Updates
As revealed in the Hygiene Products Management Act on September 26th, 2023, toothbrushes, dental floss, and other oral hygiene products manufactured to ensure oral hygiene, and to promote and maintain oral health, are added to the category of hygiene products.
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