Europe | ||||
Parameter | United States | Canada | Current | Proposed |
Regulations | Title 21 of CFR, parts 50, 54, 56, and 312 | Food and Drug Regulations, part C, division 5 | Directive 2001/20/EC, 2005/28/EC, 2003/94/EC | Regulation (EU) 536/2014 |
Submission structure | Single IND with clinical amendments for new protocols | One CTA per study | Per study | Per study |
Submission format | eCTD for commercial IND; non-eCTD for noncommercial IND | Non-eCTD, electronic only (eCTD = pilot stage) | Non-eCTD, electronic (paper cover letter plus compact disk) | eCTD (EU portal) |
Regulatory approval time | Initial study, 30 d; amendments, 0–30 d | 30 d/study | 60 d, variable for EC approval | 10 + 50 d |
Labels | Investigational use statement | Investigational use statement (in English and French); sponsor and protocol number | Sponsor, EudraCT number, investigational use statement | Simplified for diagnostic radiopharmaceuticals |
Annual report | Required | NA | NA | NA |
Fees | None | None | National | National |
Ethics approval | Required (institutional review board) | Required (research ethics board) | Required (EC) | Integrated in centralized evaluation process |
Database | www.clinicaltrials.gov | Health Canada–managed database (www.clinicaltrials.gov recommended) | EudraCT, EU Clinical Trials Register | EudraCT, EU Clinical Trials Register |
Record retention | 2 y after FDA approval or after last patient administration; notify FDA | 25 y | 5 y after completion of trial (in certain cases ≤30 y) | 25 y (for advanced therapy medicinal products, 30 y) |
Financial disclosure | Required | NA | NA | NA |
Safety reporting to authority | Life-threatening SUADR, 7 d; SUADR, 15 d | Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d | Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d | Life-threatening SUADR, 7 d (+8 d follow-up); SUADR, 15 d |
CFR = Code of Federal Regulations; EC = European Commission; eCTD = electronic common technical document; NA = not applicable; SUADR = serious unexpected adverse drug reaction.