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Comparison of Approval Process for Nonprescription Drugs in Different Countries

비처방의약품 허가 제도의 국가별 비교 연구 및 고찰

  • Kim, Joo Hee (College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University) ;
  • Yee, Jeong (College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University) ;
  • Lee, Gwan Yung (College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University) ;
  • Lee, Kyung Eun (College of Pharmacy, Chungbuk National University) ;
  • Gwak, Hye Sun (College of Pharmacy and Division of Life and Pharmaceutical Sciences, Ewha Womans University)
  • 김주희 (이화여자대학교 약학대학) ;
  • 이정 (이화여자대학교 약학대학) ;
  • 이관영 (이화여자대학교 약학대학) ;
  • 이경은 (충북대학교 약학대학) ;
  • 곽혜선 (이화여자대학교 약학대학)
  • Received : 2018.08.22
  • Accepted : 2018.10.25
  • Published : 2018.12.29

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.

Keywords

References

  1. Health at a Glance 2017: OECD Indicators. 2017. Available from http://www.oecd.org/health/health-systems/health-at-a-glance-19991312.htm. Accessed August 1, 2018.
  2. Dukes M, Haaijer-Ruskamp F. Drugs and money: prices, affordability and cost containment. WHO report 2003. Available from http://apps.who.int/medicinedocs/en/d/Js4912e/. Accessed August 1, 2018.
  3. The value of OTC medicine to the United States. Consumer Healthcare Products Association report 2012. Available from https://www.chpa.org/OTCValue.aspx. Accessed August 1, 2018.
  4. The socioeconomic perspectives of general sales of over-the-counter (OTC) medicines outside of pharmacy. Research Institute for Healthcare Policy Korean Medical Association. 2013. Available from http://webzine.rihp.re.kr/webzine_201211/w_10.html. Accessd August 1, 2018.
  5. Pharmaceutical Industry Analysis. Korea Health Industry Development Institute Report 2017. Available from https://www.khidi.or.kr/eps. Accessed August 1, 2018.
  6. Guide to Drug Approval System in Korea. National Insitute of Food and Drug Safety Evaluation. 2017. Available from https://www.mfds.go.kr/eng/index.do?nMenuCode=126. Accessed August 1, 2018.
  7. Regulation on drug product authorization, declaration and review. Korea Food and Drug Administration. 2015. Available from http://www.nifds.go.kr/eng/index. Accessed August 1, 2018.
  8. Drug development. Pharmaceutical Administration and Regulations in Japan. Regulatory Information Task Force of Japan Pharmaceutical Manufacturers Association. 2017. Available from http://www.jpma.or.jp/english/parj/whole.html. Accessed August 1, 2018.
  9. The Regulatory Affaris of Pharmaceutical Society. Over-the-Counter (Nonprescription) Drug Products, In: Fundamentals of US Regulatory Affairs, 10th ed, Rockville, RAPS, 2017;167-78.
  10. The Regulatory Affaris of Pharmaceutical Society. Overview of Authorisation Procedures for Medicinal Products, In: Fundamentals of EU Regulatory Affairs, 8th ed, Rockville, RAPS, 2017;252-69.
  11. The Regulatory Affaris of Pharmaceutical Society. Nonprescription Medicinal Products, In: Fundamentals of EU Regulatory Affairs, 8th ed, Rockville, RAPS, 2017;360-9.
  12. Borg JJ, Laslop A, Pani L, et al. Reflections on Decisions Made on the Well-Established Use of Medicinal Prducts by EU Regulators and the ECJ. Sci Pharm 2014;82:655-63. https://doi.org/10.3797/scipharm.1402-14
  13. The Regulatory Affaris of Pharmaceutical Society. Nonprescription Drugs, In: Fundamentals of Canada Regulatory Affairs. 4th ed, Rockville, RAPS. 2014; 140-7.
  14. Anand K, Mallu UR, Kuraku M, et al. Pharmaceutical drug products approval procedure in Australia. Exp 2013;11(3):690-705.