Ministry of food and drug safety

Ministry of food and drug safety

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Approval Process

Overview

Overview of Pharmaceutical Approval Process
  • Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and inspection for their manufacturing and distribution.(「Pharmaceutical Affairs Act」Article 31)
    • Classification of pharmaceuticals : Drug products, pharmaceutical ingredients
    • Classification of drug products : New Drug, Pharmaceutical required for data submission and Generic Drug
      • New Drug 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 Affairs Act」Article 2 Subparagraph 8)
      • Pharmaceutical required for data submission refers to not a new drug but a pharmaceutical required for the safety and efficacy evaluation. (Regulation on Pharmaceuticals Approval, Notification and Review (MFDS Notification) Article 2 Subparagraph 8) 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
Data Requirements for Approval
  • New Drug (「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 9)
    • (Review by Drug 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)
Figure 1. Dossier for Safety & Efficacy Evaluation
Data on Drug Substance
  1. Data on structure identification
  2. Data on physical & chemical properties
  3. Data on manufacturing methods
  4. Data on specifications & test methods are stated
  5. Supportive data on specifications & test methods
  6. Data on test results
  7. Data on reference standards, reagents, and test solutions
  8. Data on containers & packaging materials
Data on drug product
  1. Data on drug product
  2. Data on composition
  3. Data on manufacturing methods
  4. Data on specifications & test methods are stated
  5. Supportive data on specifications & test methods
  6. Data on test results
  7. Data on reference standards, reagents, and test solutions
  8. 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. 「Regulation on Safety of Pharmaceuticals」(Ordinance of the Prime Ministerial) Article 4 (1) 3
    • Generic drugs are reviewed by Drug Evaluation Department and approved by regional FDAs.
Work Flow for Approval of Pharmaceuticals
  • New drug, Pharmaceutical required for data submission
  • In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary
  • Product Manager (PM) a general manager from submission, pre-review, supplementation, approval and revision for each product
  • Pre-review system : PM examines submission data and the adequacy of data requirements
  • Product Briefing
    • (Priority) new drug, IMD and when requested by civil petitioner
    • (Participants) civil petitioner, Review Division, Pharmaceutical Policy Division
      Improve efficiency and predictability of review and approval process by enhancing mutual understanding between reviewer and petitioner of a product required for approval process
    • Drug Approval Update
      Weekly withdrawals, monthly approvals, approval report (NDA), evaluation results of safety and efficacy (pharmaceuticals required for data submission)
  • Generic Drug
    • Required Application Documents : Bioequivalence study, GMP documents and CMC(Chemistry, Manufacturing, Controls) data
Figure 1. the Process of Generic Drugs Approval
  • RFDA approve generic drugs via drug approval evaluation
  • In the whole process of drug review and approval, consult with Central Pharmaceutical Affairs Advisory Committee (CPAC), if necessary.