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논문KCI 등재후보

전문가 의견 기반 의약품 광고 가이드라인 및 심의 규정 개선방안

Improvement of the Drug Advertisement Guideline and Review Regulation Based on Expert Opinions

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Objectives: To identify areas for improvement in the drug advertisement guidelines and review regulations. Methods: Expert opinions was collected from individuals who have served as members of drug advertisement review committees. This study focused on two areas: opinions on the necessity for improvement by types of inappropriate advertisement specified in the guidelines for drug advertisement and the possibility of allowance by unpermitted advertisement expressions presented in the detailed review regulations for drug advertisement. Results: Regarding the types of advertisement outlined in the guidelines, “advertisement with citation of literature” was identified as the most in need of improvement. In the detailed review regulations, there was a consensus that expressions such as “chronic” rhinitis and “cooling effect from menthol added to patches” require permission, with the highest agreement (7 respondents, 46.7%). Furthermore, when consolidating specific opinions on the possibility of allowance, it was noted that permission might be granted with clear evidence and if expressions are perceived as common by consumers. Conclusions: The findings could serve as valuable reference material for future revisions of the drug advertisement guideline and review regulations.

Abstract

Objectives: To identify areas for improvement in the drug advertisement guidelines and review regulations. Methods: Expert opinions was collected from individuals who have served as members of drug advertisement review committees. This study focused on two areas: opinions on the necessity for improvement by types of inappropriate advertisement specified in the guidelines for drug advertisement and the possibility of allowance by unpermitted advertisement expressions presented in the detailed review regulations for drug advertisement. Results: Regarding the types of advertisement outlined in the guidelines, “advertisement with citation of literature” was identified as the most in need of improvement. In the detailed review regulations, there was a consensus that expressions such as “chronic” rhinitis and “cooling effect from menthol added to patches” require permission, with the highest agreement (7 respondents, 46.7%). Furthermore, when consolidating specific opinions on the possibility of allowance, it was noted that permission might be granted with clear evidence and if expressions are perceived as common by consumers. Conclusions: The findings could serve as valuable reference material for future revisions of the drug advertisement guideline and review regulations.

참고문헌 (13)

  1. Ministry of Food and Drug Safety, "Guideline for advertising pharmaceuticals and providing information on prescription drugs", Ministry of Food and Drug Safety, ~ (2022)
  2. Cho YK, "The legal consideration on the medicine advertising regulation in Korea-basing on the pharmaceutical affairs act-", J Law Polit Res, 11, pp.995~1017 (2011)
  3. Korea Pharmaceutical and Bio-Pharma Manufacturers Association, "30 years of medicine advertising review, its meaning and way to go" (2020), Korea Pharmaceutical and Bio-Pharma Manufacturers Association
  4. Korea Pharmaceutical and Bio-Pharma Manufacturers Association, "Practical manual for medicine advertising review" (2023), Korea Pharmaceutical and Bio-Pharma Manufacturers Association
  5. Han BH, "Self-medication and the pharmacy profession", Yakhak Hoeji, 47, pp.252~259 (2003)
  6. Park JW, "A study on the analysis of related laws and regulations for the improvement of drug advertising review act", Reg Res FDC, 18, pp.53~61 (2023)
  7. Kim J, "Expert opinion survey to improve criteria and procedures of drug advertisement review", J Korean Acad Soc Managed Care Pharm, 11, pp.24~38 (2023)
  8. 이석준, "2013년서 멈춘 일반약 광고 심의 규제…손질 필요", 데일리팜, ~ (2022)
  9. Cho WY, "Five-year trends in drug advertisement review by the anatomical and therapeutic classification of pharmaceutical products and factor analysis for improvement of quality of advertisement", J Pharm Soc Korea, 67, pp.318~323 (2023)
  10. "[Internet"[URL]
  11. Study on improvement of system for drug advertisement review, "Cheong JH", Korea Pharmaceutical and Bio-Pharma Manufacturers Association, ~ (2022)
  12. 정새임, "‘셀프메디케이션’ 시대, 의약품 광고 심의 어떻게 달라져야 할까", 청년의사, ~ (2019)
  13. 정새임, "건기식은 자유로운데...’안 되는 것’ 많은 일반약 광고", 데일리팜, ~ (2022)

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