Sponsor CRO SMO CRA Monitor Audit Investigator Approval

임상시험조직 Sponsor, CRO, SMO CRA Monitor & Audit Investigator Approval Subjects Inspect Hospital Support Approval CRSC IRB Inspect KFDA

신약임상평가 개발의 변화 (2) 2. ICH GCP 에 따른 변화 1)Human Pharmacology 2)Therapeutic Exploratory Trial 3)Therapeutic Confirmatory Trial 4)Therapeutic Use Trial

Pharmaceutical Market Worldwide 2000 Rank 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Country GBP (Billion) USA Japan Germany France Italy UK Spain China Brazil Canada Mexico S. Korea Argentina India Australia 94. 5 36. 2 12. 1 11. 6 7. 3 7. 2 4. 1 4. 0 3. 2 2. 7 2. 6 2. 4 1. 8 1999 Rank 1 2 3 4 5 6 7 9 8 10 11 13 12 14 15 1998 Rank 1 2 3 4 5 6 8 9 7 10 12 14 11 13 15 1997 Rank 1 2 3 4 5 6 8 9 7 10 12 15 11 14 16 1996 Rank 1 2 4 3 5 6 8 7 13 9 15 12 10 N/A 17

Regulatory Approval Time Example: Pegasys Ph III study regulatory approval time (Month) Source: Roche