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Impact of International regulatory collaboration on Pharmaceutical trade

국가 간 의약품 규제 협력이 의약품 무역에 미치는 영향

  • Jaeyoun Roh (Yeungnam University, School of International Economics & Business) ;
  • Iyn-Hyang Lee (Yeungnam Univeristy, College of Pharmacy)
  • Received : 2022.09.28
  • Accepted : 2022.10.27
  • Published : 2022.10.30

Abstract

Tariffs on pharmaceuticals are generally low, but the time-consuming and costly licensing procedures of importing countries may act as barriers to trade. Accordingly, in terms of improving export competitiveness through cost reduction of exporting countries and improving public health for importing countries, international regulatory collaboration is effective for both countries. However, little is known about the impact of cross-border cooperation in pharmaceutical regulation on international trade. This study empirically analyzed the effect of cross-border regulatory collaboration on pharmaceutical trade using the gravity model. It was confirmed that the regulatory collaboration measures had a trade promotion effect in all drugs(HS29+HS30), finished drugs (HS30), and vaccines (HS300220). This study is meaningful in that it empirically analyzed with the consideration of the reference pharmacopoeia, safety and effectiveness in addition to the GMP inspection used in the previous study.

Keywords

Acknowledgement

This work was supported by the Ministry of Food and Drug Safety.

References

  1. Cavaller Bellaubi M, Harvey Allchurch M, Lagalice C, and Saint-Raymond A. (2020) "The European Medicines Agency facilitates access to medicines in low- and middle-income countries", Expert Review of Clinical Pharmacology, 13(3), pp 321-325, doi:10.1080/17512433.2020.1724782.
  2. Giralt AN, Ronse M, and Ravinetto R. (2020), "A survey of nongovernmental organizations on their use of WHO's prequalification programme" Bulletin of the World Health Organization, 98(6), pp 413-419, doi:10.2471/blt.19.233882.
  3. Head, K., "Gravity for beginners", mimeo, University of British Columbia, 2003.
  4. Lee, Iyn-Hyang, Jin-Won Kwon, Yun-Kyoung Song, Seung-Mi Lee, Eun-Hye Park, and Siachalinga Linda. (2021) Study on reference country in the market authorization for pharmaceuticals to set up strategies for overcoming non-tariff barriers. Ministry of Food and Drug Safety, Research Cooperation Foundation of Yeungnam University.
  5. Luigetti R, Bachmann P, Cooke E, and Salmonson T. (2016). Regulatory collaboration. WHO Drug Information, 30(4), 558-566.
  6. Marrelli AF, Tondora J, and Hoge MA. (2005). Strategies for developing competency models. Administration and Policy in Mental Health, 32(5-6), pp533-61. https://doi.org/10.1007/s10488-005-3264-0
  7. Shin, Ho-chul and Moo-sup Jung (2020). "The Effect of GMP MRA on Bilateral Trade Flows", Korea Trade Review, 20(1), 177-193.
  8. tHoen EF, Hogerzeil HV, Quick JD, and Sillo HB. (2014), "A quiet revolution in global public health: The World Health Organization's Prequalification of Medicines Programme", Journal of Public Health Policy, 35(2), pp 137-161. doi:10.1057/jphp.2013.53.
  9. Wang Seung-hye and J. Sun. (2019) "Research on mutural recognition legislation for global regulatory cooperation". Korea Legislation Research Insititute.