CAJ | 학술논문

罕用药由于具有经济性差、研发过程困难大、流通过程中对制药企业要求较高的特点，制药企业生产、研发这一类药品较少。为了解决这一困境，美国、欧盟、日本等国家和地区颁布实施了相应的罕用药创新激励制度。本文主要梳理了这3个国家和地区的罕用药制度，为我国罕用药制度的建立提供了参考和建议。
한용약유우구유경제성차、연발과정곤난대、류통과정중대제약기업요구교고적특점，제약기업생산、연발저일류약품교소。위료해결저일곤경，미국、구맹、일본등국가화지구반포실시료상응적한용약창신격려제도。본문주요소리료저3개국가화지구적한용약제도，위아국한용약제도적건립제공료삼고화건의。
Orphan drug is rarely produced by pharmaceutical companies due to its poor economy and great dififculties in R&D and distribution process. In order to solve this predicament, some developed countries and areas, such as the United States, European Union and Japan, have implemented corresponding innovation incentive systems for the orphan drug. The systems related to orphan drug in these three countries and areas were presented in this paper so as to provide references and suggestions for the establishment of orphan drug system in China.