신약 승인 절차의 영향요인에 관한 연구
The Study on the Factors Influencing New Drug Approval
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의약분업 시행 이후 의약품 품질에 대한 사회적 요구 증가에 따라, 정부는 의약품의 품질향상과 안전성 확보를 위여 신약 승인 절차의 개선 방안을 제시하고 있다. 이러한 개선 방안의 효율화를 위하여, 국내의 의약품 승인과 관련된 의사결정에 영향을 미치는 외부 요인을 파악하는 것이 필요하다. 본 논문에서는 규제기관의 의사결정 이론 중 하나인 External signals model을 적용하여, 국내 의약품 승인 절차에 영향을 미치는 제약 산업의 환경적 요소에 대하여 분석하였다. 이를 위하여 신약의 승인 자료, 약물학적 혁신성, 약효군 및 신약을 승인받은 회사의 매출액, 연구비, 누적 승인 수, 국적의 자료를 사용하여 회귀분석을 시행하였다. 연구결과 약효군별 신약의 승인 소요 기간의 평균은 통계적으로 유의하게 다른 것으로 나타났다. 특히 조직세포의 기능용 의약품과 순환계용약과 같이, 해당 적응증의 복잡성이 높은 신약의 경우 다른 약효군에 비하여 평균 승인 기간이 긴 것으로 나타났다. 또한 신약을 승인받은 회사의 특징 중, 매출액과 누적 승인 수는 승인시간에 양의 영향력을, 개별회사의 연구비는 통계적으로 유의한 음의 영향력을 갖는 것으로 분석되었다. 본 연구는 실증자료를 바탕으로 국내 의약품 승인에 영향을 미치는 요인에 대하여 체계적으로 분석함으로써, 효율적인 KFDA 신약 승인 절차 개선을 위한 기초 정책 자료로 활용될 수 있을 것으로 기대된다.
Abstract
In Korea, since the launch of the separation of prescription and dispensing of medicine, there has been increasing demand for quality drugs from the society, and the Korean government has been stepping up its effort to improve new drug approval process. Therefore, in this study, we aim to identify external factors that influence KFDA's drug approval decision-making process based on the External Signals Model, which was developed to understand decision-making characteristics of regulatory agencies. The results of the analysis are as follows: Fisrt, the average new drug approval time for each therapeutic category was found to be significantly different statistically. In particular, it was found that new drugs whose applicable diseases are highly complex such as functional agents of tissue cell or drugs acting on circulatory system, took a longer average time to obtain approval. Second, among the characteristics of firms that obtained approval for their new drugs, sales and cumulative number of approval were found to have positive and significant influence on approval time, while individual firm's research expenditure had negative and significant influence on approval time. This study can suggest for a more efficient new drug approval procedure by analyzing the factors that influence drug approval in Korea.
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