의약품 품목갱신제도 개선에 대한 제약업계의 인식 조사 - 유익성-위해성 평가를 중심으로

• Published in: Yaghag-hoi-ji pp. 124 - 135
• Main Authors: 박양수, 오하나, 여현석, 홍진태, 한상배
• Format: Journal Article
• Language: Korean
• Published: 대한약학회 01.04.2020
• Subjects: 약학
• ISSN: 0377-9556; 2383-9457
• DOI: 10.17480/psk.2020.64.2.124

Drug renewal system is one of the effective tools for the re-evaluation of benefit-risk for the approved drugperiodically. This study was purposed to investigate pharmaceutical industry’s perception on the improvement of drugrenewal system and benefit-risk assessment. Comparative analysis was conducted on domestic and foreign pharmaceuticalcompanies, as it is expected that the survey results would be affected by differences in product types, retention level ofdata and infrastructure. We conducted both on-line and off-line survey, which results in a total of 77 out of 255 staffsresponded from December 2019 to January 2020; most of them were working at the department of regulatory affair orpharmacovigilance. The questionnaire consisted of 3 major parts; appropriateness of the current document requirements,introduction of the benefit-risk assessment, and pharmaceutical company’s status. Sixty-five percent of the respondents saidthat the current document requirements for drug renewal were appropriate, though 77% responded that the current systemcannot assess the benefit-risk. For the introduction of benefit-risk assessment, 57% responded that it was unnecessary. Themain reason was that it was inappropriate for the domestic situation. Only 22% responded that they had a workforce forbenefits-risk assessment in the company. The overall response tendency was similar between domestic and foreigncompanies. However, for the benefit-risk assessment method, foreign companies had a higher recognition than domesticcompanies (61% vs 35%). In conclusion, it was thought that the pharmaceutical industry still had a great reluctance tointroduce benefit-risk assessment due to the lack of expertise and the burden of preparing documents. Therefore, it isneeded that infrastructure construction and sufficient training should precede for the improvement of the drug renewalsystem and the introduction of a benefit-risk assessment. KCI Citation Count: 0