Korean J Clin Pharm.  2018 Dec;28(4):263-272. 10.24304/kjcp.2018.28.4.263.

Comparison of Approval Process for Nonprescription Drugs in Different Countries

Affiliations
  • 1College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Republic of Korea. hsgwak@ewha.ac.kr
  • 2College of Pharmacy and Institute of Pharmaceutical Science and Technology, Ajou University, Gyeonggi-do 16499, Republic of Korea.
  • 3College of Pharmacy, Chungbuk National University, Cheongju 28644, Republic of Korea.

Abstract

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

Keyword

Nonprescription drugs; pharmaceutical policy; drug approval

MeSH Terms

Australia
Canada
Delivery of Health Care
Drug and Narcotic Control
Drug Approval
European Union
Health Expenditures
Japan
Korea
Nonprescription Drugs*
Nonprescription Drugs
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