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Approval Process

Organization & Main Tasks

Biopharmaceuticals and Herbal Medicines Bureau

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

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

(1)From Development to Authorization

(2)IND(Investigational New Drug Application) Review Process

(2-1) Dossier for IND

1. Development plan
2. Introduction
3. Data on structural identification and psychochemical and biological properties (including data for a placebo)
4. Data on non-clinical studies
   1. Data on Pharmacology
   2. Data on Toxicity
5. Data on clinical studies (if applicable)
6. Study protocol
7. References
8. Investigatorí»s Brochure (IB)

(3) NDA (New Drug Application) Review Process

(3-1) Dossier for NDA(BLA)