의약품 품목갱신제도 개선에 대한 제약업계의 인식 조사

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Drug renewal system is one of the effective tools for the re-evaluation of benefit-risk for the approved drug periodically. This study was purposed to investigate pharmaceutical industry’s perception on the improvement of drug renewal system and benefit-risk assessment. Comparative analysis was conducted on domestic and foreign pharmaceutical companies, as it is expected that the survey results would be affected by differences in product types, retention level of data and infrastructure. We conducted both on-line and off-line survey, which results in a total of 77 out of 255 staffs responded from December 2019 to January 2020; most of them were working at the department of regulatory affair or pharmacovigilance. 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 said that the current document requirements for drug renewal were appropriate, though 77% responded that the current system cannot assess the benefit-risk. For the introduction of benefit-risk assessment, 57% responded that it was unnecessary. The main reason was that it was inappropriate for the domestic situation. Only 22% responded that they had a workforce for benefits-risk assessment in the company. The overall response tendency was similar between domestic and foreign companies. However, for the benefit-risk assessment method, foreign companies had a higher recognition than domestic companies (61% vs 35%). In conclusion, it was thought that the pharmaceutical industry still had a great reluctance to introduce benefit-risk assessment due to the lack of expertise and the burden of preparing documents. Therefore, it is needed that infrastructure construction and sufficient training should precede for the improvement of the drug renewal system and the introduction of a benefit-risk assessment.