CAJ | 학술논문

本文通过分析我国创新药品可获得性现状与影响因素，在理论上分析基础上，比较左乙拉西坦（Keppra）在中美上市准入情况与数据保护强度，探究药品数据保护与创新药品可获得性之间的关系。药品数据保护制度可有效促进国外创新药品尽快进入我国市场。建议我国尽快完善药品数据保护制度，以期提高我国新药可获得性，保障公众健康福利。
본문통과분석아국창신약품가획득성현상여영향인소，재이론상분석기출상，비교좌을랍서탄（Keppra）재중미상시준입정황여수거보호강도，탐구약품수거보호여창신약품가획득성지간적관계。약품수거보호제도가유효촉진국외창신약품진쾌진입아국시장。건의아국진쾌완선약품수거보호제도，이기제고아국신약가획득성，보장공음건강복리。
The situation of marketing approval and the data protection strength of Keppra were compared between China and America by theoretical analysis of status quo of the availability of innovative drug and the influencing factors in China, so as to explore the correlation between data protection system and innovative drug availability. We thought that drug data protection system could effectively facilitate the foreign innovative drug to enter Chinese market. A suggestion on the improvement of drug data protection system as soon as possible in China was proposed so as to enhance new drug availability in China and ensure public health welfare.