Regulatory Affairs

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Regulatory Affairs

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