International Regulations

International Council for Harmonization (ICH)

Belmont Report

US Regulations:

45 CFR Part 46 Protection of Human Subjects

21 CFR Part 50 Protection of human subjects and part 56 Institutional Review Boards

21 CFR Part 54 Financial disclosure by Clinical Investigator

21 CFR Parts 312 (investigational New Drug Application) and part 314 (Application for FDA Approval to Market A New Drug)

21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies

Indonesia Regulation:


Important Link: