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)
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)
  • Generic Drug
  • 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