New narcotics are appearing frequently all around the world, and health authorities are busy to cope with these. Because Korea has no specific article about drug designation in narcotic act, drug list of its enforcement ordinance should be amended whenever new narcotics appear. Such a procedure is time-consuming and ineffective. Some related statutes of other countries were investigated to improve this. An emergency procedure of USA and Germany which designates individual drugs temporarily omitting some procedure in urgent cases was introduced to our act on June, 2011. An analogue system of USA that a substance which has a substantially similar chemical structure with a controlled substance will be treated as a controlled substance is effective to cope with newly appearing derivatives, but the definition is too vague. The scope of each analogue is definite in New Zealand and UK, but the scientific background is not clear. For urgent improvement, some analogues were added to our drug list on February, 2011 based on Canadian analogue system.
목차
초록 I. 서론 II. 연구 방법 III. 임시지정 제도의 도입 1. 임시지정 제도 2. 신속지정 제도 3. 임시지정 제도의 국내 도입 IV. 아날로그 제도의 도입 1. 아날로그 제도 2. 제네릭 제도 3. 아날로그 제도의 국내 도입 V. 결론 감사의 말 참고문헌 Abstract
한국에프디시규제과학회(구 한국에프디시법제학회) [The Korean Society of Food, Drug and Cosmetic Regulatory Sciences]
설립연도
2006
분야
의약학>약학
소개
본회는 의약품, 의약외품, 의료기기, 화장품 및 건강기능식품 등과 관련된 국내·외의 각종 법령과 규정 등에 대한 연구와 발표 등을 통하여 합리적이고 투명한 법령과 규정의 제·개정 및 정책개발에 기여함으로써 관련 산업의 발전과 국민의 건강증진에 기여하며 회원 상호 간의 친목을 도모함을 목적으로 한다.
간행물
간행물명
KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]