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Table 1 Convergence in International Medicines Regulatory Standards

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

  1. aAbraham and Reed [46]
  2. bAbraham and Reed [47]
  3. cYu, Bischoff and Tweedie [48]
  4. dCastle and Kelly [49]; Kesselheim et al. [50]
  5. eIn certain cases, non-rodent studies of up to 6 months can be appropriate in Japan and the US [51]. Shorter non-rodent toxicity studies are for example allowed when immunogenicity or intolerance confounds conduct of longer term studies; in cases of repeated short-term drug exposure even if clinical trial duration exceeds 6 months; for drugs administered on a chronic basis to reduce the risk of recurrence of cancer; and for drugs for indications for which life expectancy is short
  6. fFDA written responses to interview questions [51]
  7. gFaden and Milne