Biological Products

Organization & Main Tasks

Biopharmaceuticals and Herbal Medicines Bureau
Biopharmaceuticals and
Herbal Medicines Bureau
  • Biopharmaceutical
    Policy Division
  • herbal Medicines
    Policy Division
  • Cosmetics
    Policy Division
  • Quasi-drugs
    Policy Division
Biopharmaceutical Policy Division
  • Establishes & coordinates safety management policies for biopharmaceuticals; creates & revises policies for biopharmaceuticals, transplantation materials and blood plasma
  • Supports exports and involves in international cooperation
Biopharmaceutical Quality Management Division
  • Establishes & runs comprehensive domestic/international inspection plans regarding biopharmaceutical manufacturing, quality management criteria and human transplantation materials management
  • Establishes & coordinates biopharmaceutical supervision/monitoring plans; establishes/runs GMP training/capability building plans
Herbal Medicines Policy Division
  • Establishes and coordinate policies; implement and revise rules and regulations; engage in international cooperation; grant market authorization of domestically-manufactured/imported products & develop relevant policies in herbal medicines
Cosmetics Policy Division
  • Establishes and coordinate policies; implement & revise rules, regulations and notifications; make and coordinate monitoring plans in cosmetics products
Quasi-drugs Policy Division
  • Establishes and coordinate policies; implement & revise rules, regulations and notifications; make and coordinate monitoring plans; grant market authorization of domestically-manufactured/imported products & develop relevant policies in quasi drugs
Biopharmaceuticals and Herbal Medicines Evaluation Department
Biopharmaceuticals and Herbal
Medicines Evaluation Department
  • Biologics Division
  • Recombinant
    Product Division
  • Gene and Cell
    Therapy Products Division
  • Herbal Medicines
    Products Division
  • Cosmetics
    Evaluation
    Division
Biologics Division
  • Reviews & evaluates quality, safety and efficacy of biologics & biopharmaceutical diagnostics products
  • Approves domestic and import related products
Recombinant Products Division
  • Reviews & evaluates quality, safety and efficacy of recombinants
  • Approves domestic and import related products
Cell and Gene Therapy Products Division
  • Reviews & evaluates quality, safety and efficacy of cell therapies, gene therapies, tissue-engineered products
  • Approves domestic and import related products
Herbal Medicines Products Division
  • Reviews & evaluates quality, safety and efficacy of herbal medicines
  • Approves domestic and import related products
Cosmetics Evaluation Division
  • Reviews & evaluates quality, safety and efficacy of cosmetics and quasi medicines
  • Approves domestic and import related products
Control of Biologics

Approval Process

From Development to Authorization
Sponsors have submitted application as electronic documents through KiFDA online system since Oct. 2nd , 2006.
IND(Investigational New Drug Application) Review Process
  • Dossier for IND
    • Development plan
    • Introduction
    • Data on structural identification and psychochemical and biological properties (including data for a placebo)
    • Data on non-clinical studies
      • Data on Pharmacology
      • Data on Toxicity
    • Data on clinical studies (if applicable)
    • Study protocol
    • References
    • Investigator’s Brochure (IB)
NDA (New Drug Application) Review Process
  • Dossier for NDA(BLA)