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박실비아 ( Park Sylvia ),채수미 ( Chae Su-mi ),박은자 ( Park Eun-ja ),주민희 ( Ju Min Hui ),구현민 ( Gu Hyun Min ),유원곤 ( Yoo Won Kon ) 한국보건사회연구원 2013 保健社會硏究 Vol.33 No.2
희귀의약품은 소수의 환자들이 앓는 희귀질환 치료제로서 시장의 크기가 작아 제약기업의 개발 동기가 낮다. 이에 미국, EU, 일본 등 국가는 제도적 개입을 통하여 희귀의약 품의 개발을 촉진해왔다. 우리나라는 희귀의약품의 수입을 통한 공급 위주의 정책을 시행해왔으나, 연구개발 역량이 향상됨에 따라 희귀의약품 개발이 증가하고 있으며 이에 따라 희귀의약품의 정책의 전환이 필요하다. 이 연구는 희귀의약품의 연구개발 국가인 미국, EU, 일본과 우리나라의 희귀의약품 제도를 비교분석하였다. 미국과 EU, 일본은 연구개발 단계에서부터 희귀의약품을 지정하여 연구개발을 직간접적으로 지원하고 있다. 우리나라에서는 희귀의약품의 허가 및 시판후 관리에서 안전성, 유효성에 대한 평가를 일부 완화하고 있으나, 다른 국가들에서는 희귀의약품이라는 이유로 절차를 완화하고 있지는 않았다. 향후 국내에서 개발되는 희귀의약품이 증가할수록 우리나라에서도 희귀의약품의 연구개발 단계에서의 지원프로그램이 필요하며, 안전성, 유효성에 관한 시판전후 평가를 강화할 필요가 있다. This study investigated orphan drug policies of Korea, US, EU, and Japan and compared them. We focused on orphan drug designation, R&D support program, marketing authorization, and market exclusivity. The US, EU, and Japanese governments have provided various incentives for orphan drug development including research grants, tax credits for development costs, protocol assistances, and market exclusivity. Those countries designate products as orphan drugs eligible for the supporting programs during the R&D phase. In Korea, the primary purpose of orphan drug policy has been accelerating the provision of orphan drugs most of which are imported drugs developed in other countries. Therefore, designation of orphan drug has been only possible at the marketing approval phase and there have been few R&D support programs. In addition, the regulatory authority has partly skipped evaluation of efficacy and safety. These days, however, there has been much progress in new drug research capacity and increasing number of ongoing projects for orphan drug development in Korea. Considering these changes, orphan drug policy of Korea needs to shift to accelerating drug development and ensuring safety and efficacy through the regulatory process.
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홍은정,유성희,정선회,박경호,손인자,조윤경,구현민,장영수 韓國病院藥師會 2004 병원약사회지 Vol.21 No.2
Orphan drugs are used for rare disease, the number of domestic patients suffering from such disease being no more than 20,000 or for disease for which no treatment or no alternative medicine is yet. Orphan drugs are supplied by pharmaceutical companies or by Korea Orphan Drug Center(KODC). Presently, there are total 93 kinds of orphan drugs designated as such by the relevant laws, and Seoul National University Hospital(SNUH) has 49 kinds(53%) of them(as of June 2003). The purpose of this study was to analyze usage of orphan drugs prescribed by SNUH and to improve of the related pharmacy services for effective treatment of patents of the rare disease. We analyzed usage of orphan drugs inside and outside of SNUH, gender of patients, related clinical departments and frequency of use for the period from Jan. 2001 to June 2003. For the purpose, we used KODC data of use by patients in SNUH. The use of orphan drugs in SNUH sharply increased from 2000 through 2001 and was steadily increasing since then. The ratio of usage inside to outside SNUH was 92 to 8(as of June 2003). The clinical department that prescribed the orphan drugs most frequently was the internal medicine department(74~84%). The most frequently used drugs were antiviral agents(74%, oral drug) and antineoplastics(58%, injectable drug). KODC supplied 6 kinds of orphan drugs in 2002 and 4 kinds in the first half of 2003 to SNUH patients. The proportion of SNUH patients to the total patients who used orphan drugs supplied by KODC was very variable. (dantrolen 0.46% ~ ganciclovir 50.5%).
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