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Regulatory Affairs

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Subject

Approval:Item needing safety and efficacy review and intensive management

Even if safety and efficacy are proved,

① War-nings in the label should be rechecked and approval standard should be reconsidered after
② The drug needs to be reviewed to prevent risk factors

Notification:Items that doesn't need safety and efficacy review

① The drug is already stated in the Korean and U.S. Pharmacopeia, obtaining safety and efficacy approval
② Proper pre-management is enough

Drug Approval Process

Applicant - Drug Evaluation-Drug Approval&Review Management Division, KFDA - applicant

Research and development of drug

Prepare data for drug approval (Article 31, 42 of Pharmaceutical Affairs Law )

Write a preliminary report

- Application Outline

- Examine the application

Review result of preliminary review

Review of technology by an area

- Safety/efficacy data

- Standard and assay

- Bioequivalence and compare clinical trials

- GMP / DMF data, etc

Review of social impact

Issuing the certificate of approval

Release result of drug approval