MFDS - Ministry Of Food And Drug Safety

Home

DRUG

Main Task

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

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

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 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

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