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KMID : 1170320070130020017
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Korean Journal of Health Economics and Policy
2007 Volume.13 No. 2 p.17 ~ p.37
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The Study on the Factors Influencing New Drug Approval
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Jung Kee-Taig
Lee Kyung-Jin
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Abstract
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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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KEYWORD
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New Drug Approval, Decision Making, External Signal Model
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