초록 ▼

연구결과
필요성 및 목표
○ 나노의약품의 허가·심사를 위하여 나노기술(나노물질) 특성이 반영된 기존 의약품과 차별화된 기술정보 사전조사
○ 나노의약품은 나노기술(나노물질)이 접목된 신약·개량신약으로 글로벌 경쟁력 강화를 위해 선진 규제당국의 사례 연구 필요
○ 나노기술(나노물질)을 적용한 나노의약품의 허가·심사를 위한 시험법 조사 방법 및 결과
○ 나노기술(나노물질)이 적용된 나노의약품의 기술정보 수집
- 나노기술 및 나노의약품 용어 사용 조사
- 나노의약품에 적용되고 있는 나노기술 조사

연구결과
필요성 및 목표
○ 나노의약품의 허가·심사를 위하여 나노기술(나노물질) 특성이 반영된 기존 의약품과 차별화된 기술정보 사전조사
○ 나노의약품은 나노기술(나노물질)이 접목된 신약·개량신약으로 글로벌 경쟁력 강화를 위해 선진 규제당국의 사례 연구 필요
○ 나노기술(나노물질)을 적용한 나노의약품의 허가·심사를 위한 시험법 조사 방법 및 결과
○ 나노기술(나노물질)이 적용된 나노의약품의 기술정보 수집
- 나노기술 및 나노의약품 용어 사용 조사
- 나노의약품에 적용되고 있는 나노기술 조사
○ 나노기술이 적용된 나노의약품 품목 허가 현황 조사
○ 의약품 규제당국의 나노의약품 관련 허가·심사 가이드라인 등 조사
○ 학술대회·워크숍·세미나를 통한 나노의약품 관련 정보 수집

Abstract ▼

Nano-technology has attracted increasing attention during 80's. People considered it as an emerging technology. The studies on Nano-technology has begun in earnest in the beginning of the 21st century. Nano-technology(or Nano-material) is also expected to be the solution that could overcome the limi

Nano-technology has attracted increasing attention during 80's. People considered it as an emerging technology. The studies on Nano-technology has begun in earnest in the beginning of the 21st century. Nano-technology(or Nano-material) is also expected to be the solution that could overcome the limitation of newly invented technology. Its unlimited possibilities are predicted that scientists have actively started study and research this technology by applying it to medicine and medical device. In particular, we could expect a Nano-medicine. Once nano-technology was applied to medicine, this product could increase bioavailability of any nano-medicine. This product could diagnose a disease as well as treat the disease by delivering a nano-medicine to a specific area.
In this study, informations of nano-technology that are related to Drug Delivery System are collected and approval data and guidances of nano-medicine from U.S.A., Europe, Japan are analyzed. Worldwide conferences, workshops, seminars schedules on nano-medicine are studied to understand a national interest trend on nano-medicine. This study provides reviews of journal articles related to nano-medicine or nano-drug. In overall, this study develops current status of studies on nano-medicine and plans the future direction. It also provides regulation and related information to suggest a management plan for nano-medicines' approval and review. The nano-material test methods to evaluate nano-medicines are studied and compared with U.S.A., Europe, Japan, and Korean pharmacopoeia. Finally, this study recommends a revision direction of the Korean Pharmacopoeia.