From: Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence
 | ICH | EU | Canada | Japan | US | |
---|---|---|---|---|---|---|
 | EMA Britain France |  |  | Pre-2013 | Post-2013 | |
Pre-market standards | ||||||
 Rodent carcinogenicity tests: for medicines used for 3 or 6 monthsa | 6 months | 6 months | 6 months | 6 months | 3 months | 6 months |
 Chronic toxicity tests in animalsb | 6 months | 6 months | 6 months (pre-ICH 18 months) | 6 months (pre-ICH 12 months) | 12 months | 9 monthse |
 Length of RCTs for medicines used for chronic conditionsa | 6 months | 6 months | 6 months | 6 months | 12 months | Indication-specific |
 Timing of toxicity testsc | After initially taking medicine | After initially taking medicine | After initially taking medicine | In accordance with the drug characteristics | At steady state | Determined by the clinical development planf |
 Expedited authorization | – | Adaptive pathways | Conditional approval for life threatening conditions | Expedited approval for regenerative therapies (stem cells, gene therapy) | Fast-track for life threatening conditions | Expedited approval for serious conditions |
Post-market standards | ||||||
 ADR Reportingd | If suspect ADR relates to a medicine | If suspect ADR relates to a medicine | If suspect ADR relates to a medicine | If suspect ADR relates to a medicine | All ADRs regardless of suspected relationship to a medicine | All ADRs regardless of suspected relationship to a medicine |
 Phamacovigilance | Risk Management Plan | Risk Management Plan | Risk Management Plan | Risk Management Plan; Early post-market phase vigilance; Good post-market study practice; Re-approvalg | Risk Evaluation & Mitigation; Commissioned Sentinel data mining | Risk Evaluation & Mitigation; Commissioned Sentinel data mining |