Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

New drug classification system in accordance with global harmonization

글로벌 조화에 부합하는 국내 의약품 분류체계 개선방안

  • Sohn, Sung-Ho (Department of Pharmacy, Kyungbuk National University Medical Center) ;
  • Yoo, Bong Kyu (College of Pharmacy, Gachon University)
  • Received : 2012.07.06
  • Accepted : 2012.08.29
  • Published : 2012.09.30
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Abstract

The objective of this study was to investigate drug classification system in Korea and other developed countries. Laws and regulations of Korea regarding the system were retrieved from sources posted in Ministry of Government Legislation. We also reviewed previous research reports performed as part of government's effort to reform the system The system in the foreign countries was retrieved from the official homepage operated by each country's government. There have been two research funded by Korean government, which strongly suggested that the system should be reformed. However, we found that the system was never reformed and still effective. Drug classification system in US and most western countries consists of two categories, i.e., prescription drugs and non-prescription drugs except UK, which classifies into three categories: Prescription Only Medicines, Pharmacy Medicines, and General Sales List Medicines. Interestingly, in Japan, non-prescription drugs are further classified into three groups: Group 1, 2, and 3. Recently, Ministry of Health and Welfare (MOHW) in Korea proposed a plan to reclassify all the approved drugs according to purportedly rational and scientific criteria. However, the plan does not include reform of the existing laws and regulations, which appears that it is just one-time action rather than a sustainable administration backed up by law. Therefore, it is recommended that Korean MOHW take appropriate action on laws and regulations with regard to the system to meet global harmonization standard.

Keywords

Acknowledgement

Supported by : 가천대학교

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