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KMID : 1142220170120020139
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 2 p.139 ~ p.149
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Drug Classification Systems in Selected Countries
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Kang Dae-Won
Lim Eun-A
Bae Eun-Mi
Shin Gyeong-Seon
Lim Jae-Ok
Choi Sang-Eun
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Abstract
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Since a policy allowing over-the-counter (OTC) drug sales outside of pharmacy was implemented in 2012, Korean drug classification system was changed and it includes prescription drugs, pharmacy only OTC drugs and the new category, OTC drugs for sale outside pharmacy. Drug classification systems changed over time in foreign countries as well. In this study, we reviewed current drug classification systems in the US, UK, Japan, Sweden, the Netherlands, and Canada. In the US, drugs are classified into prescription drugs and OTC drugs. There is no restriction for place or seller for the sale of OTC medicines in the US. There are three categories in the United Kingdom, prescription only medicine (POM), and two types of OTC, pharmacy medicine (P), and general sales list (GSL) medicine. In Japan, the classification system was modified and it has pharmacy drugs, guidance-mandatory drugs and non-prescription drugs. The guidance-mandatory drug is a new category which must be sold via faceto-face consultation with a pharmacist. In Canada, there are prescription drugs, OTC drugs which can be purchased from pharmacist in pharmacy, OTC drugs which can be purchased in pharmacy, and OTC drugs that can be sold anywhere. Sweden has a similar system with UK. In the Netherlands, there are prescription drugs, pharmacy only OTC drugs, pharmacy and drugstore OTC drugs, and OTC drugs with no restriction. This study showed that while each country has its own standard of regulation for OTC drug sale, the policies are affected by general trend of liberalization in the pharmacy sector.
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KEYWORD
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medicine classification, pharmaceutical policy, prescription drugs, otc drugs
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