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Comparison of Approval Process for Nonprescription Drugs in Different Countries
Korean J Clin Pharm 2018;28(4):263-272
Published online December 31, 2018
© 2018 Korean College of Clinical Pharmacy.

Joo Hee Kim1,2, Jeong Yee1, Gwan Yung Lee1, Kyung Eun Lee3, and Hye Sun Gwak1*

1College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University, Seoul 03760, Republic of Korea
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
Correspondence to: Hye Sun Gwak, College of Pharmacy & Division of Life and Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-gil, Seoul 03760, Republic of Korea Tel: +82-2-3277-4376, Fax: +82-2-3277-2851 E-mail:
Received August 22, 2018; Revised October 24, 2018; Accepted October 25, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
Keywords : Nonprescription drugs, pharmaceutical policy, drug approval

December 2018, 28 (4)
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