韩国药物注册法规.ppt

* * Method to assess foreign clinical data * ??? ???? ??????? ??? ????. * ???? ???? ???? ?? ????? ????? ?? ?? * ???? ???? ???? ?? ????? ????? ?? ?? * Need bridging data generation before Korea NDA submission * * Pivotal trial Similar safety/efficacy between Korean/ non Korean, Korean/total patients, Asian/total patients Non pivotal multinational study Korean in multinational study/total patients in pivotal study * You can see the process of IND approval in KFDA. Sponsors submit the protocol and IB of IND to KFDA. From IND submission to IND approval it takes 30days for review. Review by IRB can be parallel with KFDA process. After approval from KFDA and IRB clinical study can start. * This slide shows the safety overview observed in this study. As previously said the rate of overall discontinuation was greater in the placebo group. The proportion of patients who experienced at least one AE was slightly higher in the rimonabant group, however looking at the SAEs the proportion of patients with SAE was quite similar between the 2 groups and interestingly the proportion of patients who discontinued due to AE was also similar. That may reflect that tolerability with rimonabant was similar to that seen with placebo. ??? ???? ?? ????? 46% ?????, ???? ??? ??? ???? ???? ??? ?? ??? ?????. Consistent results, start early, run parallel * * 1???? ???? ??? ?? ??? ?? Clinical Trial - IND Regulation - Recent Change for Early Stage Development IND Regulation Pharmaceutical Affairs Law Enforcement of Pharmaceutical Affairs Law Korean GCP Guideline CTA(IND) Guideline Guideline for Accredited Clinical Institutes Pre-Consultation IND Submission KFDA Review IND Approval IRB Submission IRB Approval Contract With Hospital Protocol, ICF (Translated), CRF IB CV IRB Committee Protocol CMC Preclinical IB KFDA Approval Process IRB Process ; Parallel review with KFDA process 1 M (average 2~3M) Study Initiation Total approval timeline : 1M Process of Approva