Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Approval Process|Bio&Cosmetics|Our Works|Ministry of Food and Drug Safety

Herbal Medicines

Summary of Pharmaceutical (Herbal Medicinal Preparations) Approval

Pharmaceutical(Herbal Medicinal Preparations) Approval
  • (Overview) Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and inspection for their manufacturing and distribution.¹
Pharmaceutical(Herbal Medicinal Preparations) Approval
Data Requirements for Approval
  • (Classification of pharmaceuticals) Drug products, pharmaceutical ingredients
  • (Classification of drug products)
    • New Drug² refers to a new material pharmaceutical whose chemical structure or original composition is totally different from a pharmaceutical previously approved in Korea or a multiple preparation containing a new material as an active drug substance, which is designated by Minister of Food and Drug Safety
    • Pharmaceutical required for data submission³ refers to not a new drug but a pharmaceutical required for the safety and efficacy evaluation
  • e.g.) pharmaceuticals with new effectiveness, new composition or increase/decrease of strength of active drug substance, and pharmaceuticals with new route of administration etc.
    • Generic Drug refers to a pharmaceutical which is equivalent to a new drug (reference drug) in terms of active ingredient, dosage form and strength
(New Drug)
  • (Review by Drug Evaluation Department, Biopharmaceuticals and Herbal Medicine Evaluation Department) Safety & efficacy data, specifications & test methods, Drug Master Files (DMF), certificate of manufacturing and marketing (Imported Pharmaceutical) Data such as name and address of manufacturers of active pharmaceutical ingredients - (Review by Other Departments) Evaluation data of conducting of Good Manufacturing Practice (GMP)
Review by Drug Evaluation Department - Data on Origin, discovery and development history Data on structure identification and physical & properties Data on Stability A. Long-term or accelerated stability test data B. Stress test data Data on Toxicity: A. Single dose toxicity B. Repeated dose toxicity C. Reproductive & developmental toxicity D. Genotoxicity E. Immunotoxicity (Antigenicity & others) F. Carcinogenicity G. Dependence H. Topical toxicity Data on Pharmaceutical Action: A. Efficacy studies data B. General pharmacological test data C. Absorption, distribution, metabolism, and excretion data Data on clinical trial reports A. Investigator’s brochure B. Bridging Data Comparative review with similar pharmaceuticals in Korea and data on their properties Data on current status of use in foreign countries Zoom
Data for Specifications & Test Method Review
  • A. Data on pharmaceutical ingredients
    • Data on structure identification
    • Data on physical & chemical properties
    • Data on manufacturing methods
    • Data on specifications & test methods are stated
    • Supportive data on specifications & test methods
    • Data on test results
    • Data on reference standards, reagents, and test solutions
    • Data on containers & packaging materials
  • B. Data on drug product
    • Data on composition
    • Data on manufacturing methods
    • Data on specifications & test methods are stated
    • Supportive data on specifications & test methods
    • Data on test results
    • Data on reference standards, reagents, and test solutions
    • Data on containers & packaging materials
  • (Pharmaceutical required for data submission) Selectively submit data required for safety and efficacy evaluation among submission data for new drug
  • (Generic Drug)? Submit bioequivalence test data and quality data instead of safety and efficacy data such as toxicity, pharmacology, clinical trials Generic drugs are reviewed by Drug Evaluation Department and approved by regional FDAs
Work Flow for Approval of Herbal Drug Products(TKMP, HMP)
  • (New drug, Pharmaceutical required for data submission)
Work Flow for Approval of Herbal Drug Products(TKMP, HMP) - Submission Herbal Medicinal product division · Based on a related regulation, evaluate user fee Pre-review Herbal Medicinal product division · Composition of preliminary report · Assign product manager (PM)* · Identify applied regulations · Check history of civil petition · Check whether requested for product briefing* · Check incrementally modified drug (IMD) etc. Review Herbal Medicinal product division Approval Herbal Medicinal product division · Designate as new drug, IMD, drug require for re·examination · Manage review results such as efficacy & effectiveness · Limit approval condition · Delist specifications · Open approval information Issue Customer Support Office · Issuing certificate of approval result Inspection of manufacturing sites and management practices · Overseas manufacturing sites (at Herbal Medicine Policy Division) · Domestic manufacturing sites (at Medical Product Safety Division at regional FDAs) Zoom
  • Generic Drug
process of drug review and approval - Process Division in charge Submission RFDA Medicinal Product Safety Division Review Biopharmaceuticals and Herbal Medicine Evaluation Department Herbal medicinal product division *Drug equivalence test data RFDA Hazardous Substance Analysis Team *specification & test method Review Biopharmaceuticals and Herbal Medicine Evaluation Department Herbal medicinal product division *Drug equivalence test data RFDA Hazardous Substance Analysis Team *specification & test method Inspection of manufacturing sites and management practices · Overseas manufacturing sites (Pharmaceutical Quality Division) · Domestic manufacturing sites (at Medical Product Safety Division at regional FDAs) Zoom
  • In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary
    • 「Pharmaceutical Affairs Act」Article 31
    • 「Pharmaceutical Affairs Act」Article 2 Subparagraph 8
    • Regulation on Pharmaceuticals Approval, Notification and Review (MFDS Notification) Article 2 Subparagraph 8, The regulation on the approval & registration of herbal drug products(TKMP, HMP) (MFDS Notification) Article 2 Subparagraph 6.
    • 「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 9
    • 「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 4 (1) 3