주요국의 의약품 사전상담제도 현황과 정책적 함의

제목
주요국의 의약품 사전상담제도 현황과 정책적 함의
Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences
저자

박실비아박은자; 한현진

키워드
pharmaceutical; consultation; pre-submission; research; development
발행연도
2008-06-30
발행기관
대한약학회
Series
약학회지, vol. 52, no. 2, pp. 151 - 159
Journal Title
약학회지
초록
Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.
ISSN
0513-4242
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