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Main Task

Pharmaceutical safety control

  • Development of policies and establishment of comprehensive plans on the pharmaceutical safety control
  • E stablishment and revision of the laws and notifications on drugs
  • Provision of information on the proper use of pharmaceuticals
  • Post-marketing safety control
  • Re-evaluation of the safety and efficacy of human placenta based pharmaceuticals
  • Introduction of Plasma Master File (PMF) system for plasma derivatives reinforcement of a management standard for imported blood plasma
  • E stablishment of guidelines on an excellent management standard for human tissues (GTP) and management of tissue bank

Pharmaceutical quality control

  • E stablishment of planning on management standards for Good Manufacturing Practices (GMP)
  • GMP inspection and evaluation for domestic and imported drugs
  • Introduction of GMP system for herbal medicines

Safety control on Narcotics

  • Review of narcotics related acts and systems
  • E stablishment/adjustment of basic plan for narcotics control, and management of statistics
  • Approval of the manufacturing, import and export of narcotics

Pharmaceutical approval and review

  • Pharmaceutical manufacturing and import approval
  • Reviewing and approval of herbal medicines and Korean traditional medicines
  • Operation of management system for pharmaceutical approval and application
  • E stablishment and operation of pharmaceutical standards such as the Korean Pharmacopoeia, etc.
  • Reviewing of the quality, safety, and efficacy of pharmaceuticals
  • Reviewing of protocols
  • Reviewing of the bioequivalence test protocols, result report, re-evaluation, etc.
  • Approval of shipping bio pharmaceuticals based on the national verification system

Establishment of basis for nurture and support

  • Supporting policies for new bio pharmaceuticals based on selection of growth engine industry
  • E stablishment of evaluation system for safety and efficacy of high tech fusion technology pharmaceuticals
  • Simplification of licensing/approval of bio pharmaceutical area
  • E stablishment of the approval and review standards for biosimilar