Quasi Drugs are one of the two primary categories of beauty products in South Korea. The other category of beauty products is cosmetics. There is a thin line between drugs and cosmetics, which can be considered as quasi-drugs. Since their benefits are not as suitable as drugs; South Korea’s health authority (HA), the Ministry of Food and Drug Safety (MFDS) has categorized them under pinpoint skincare products like acne for skin dullness. Quasi-drugs are generally classified into two coordinates:
- Items used for sanitary purposes such as sanitary pads, tampons, and menstrual pads
- The textile used for manufacturing masks such as dust and surgical masks
- Wet wipes for oral hygiene
- Sanitary products used for protection, preservation, and treatment of affected areas that includes different kinds of bandages such as eye bandage, plastic bandage, cylindrical elastic bandages, and elastic bandages. Absorbent cotton, gauze, and plaster are also a part of it.
- Odor inhibitors like toothpaste, antiperspirants, and bath products
- Hair care products that are only meant for external usage
- Products that don’t contain nicotine for those who smoke
- Contact lenses
- Ointments and anti-inflammatory products for external use
- Products for oral hygiene such as teeth whiteners, vitamin tablets, and energy drinks
- Disinfectants which are not directly applied to human beings
If a person files an application for the approval of Quasi Drug for the first time, he/she must be registered as a quasi-drug manufacturer or an importer. The registration process for quasi drugs is systematic, and it has few protocols to qualify. Listed below is the step-by-step description.
- Submission- The data must be submitted to the HA for product approval. Then for the safety and efficacy evaluation of the product will be submitted to the Cosmetics Evaluation Division (CED) and National Institute of Food and Drug Safety Evaluation (NIFDS). Lastly, for the product to be waived from safety and efficacy evaluation it will be handed over to Medical Products Safety Division, Regional Food, and Drug Safety.
- Review- After HA receives the safety and efficacy evaluations, they will review the specifications. Meanwhile, they will also inspect the manufacturing sites to assess the condition and quality of the production.
- Approval/Notification- HA will issue approval, and notification both if it qualifies in the Korean Pharmacopoeia, and other pharmaceutical compendia recognized by the MFDS.
Data Required for Approval & Notification
- Origin and development history of the drug, structure identification, physical, and chemical characteristics with specifications, and test methods
- Stability, toxicity, efficacy, and effectiveness data for the current use in foreign countries
- Comparative review with other similar products domestically manufactured, and data on the characteristics of the product
- the data demonstrating the product is subject to notification with specifications, and test methods
Processing Period and Fee
- Approval- Quasi-Drugs’ Specifications, and Test Methods (Safety and Efficacy) takes 70 working days for first approval. If done online, the charge is 695,400 KRW and 768,600 KRW through mail. For second approval, it takes 55 working days with 308,750 KRW if done online and 341,250 KRW through mail.
- Notification- In the same way, it takes 10 business days for the 1st notification with 76,950 KRW through online, and 85,0560 KRW by mail. Likewise, for the second notification, it takes 40 days with 308,750 KRW online, and 341,250 KRW through mail.
- For imported products, a certificate must be issued/attached proving the product is manufactured, and marketed according to the law of the corresponding country
- Ointments, and cataplasma which are used externally should follow Manufacturing Standards of Quasi-drugs notified by MFDS; which is necessary for inspection of good manufacturing practices (GMP)
The above mentioned are general requirements for Quasi Drug registration in South Korea. It may vary from case-to-case. What’s your requirement? Let us know. We can answer your queries and address any concerns you may have. Contact our experts at email@example.com.