A call for international harmonization in therapeutic risk management.

Therapeutic risk management is required to ensure that the benefits of a particular drug outweigh the risks in general practice. Current risk management strategies and handling of risk management and pharmacovigilance issues differ across borders. Differences in key regulatory decisions on the same product around the world, including the handling of safety issues with cisapride, dofetilide, and isotretinoin, bring into question the robustness of these decisions and the procedures currently in place to manage the risks to the public of products with potentially unfavorable risk-benefit balances. These differences may be partly due to differences in health care systems, regulatory requirements and procedures, and cultures. Greater international harmonization in approaches to risk management potentially would improve safety of medicines around the world by developing a greater uniformity in acquiring and interpreting risk-benefit evidence. The appropriateness and effectiveness of risk management interventions in different regions should be examined, and international strategies should be 'fine-tuned' for each regional health care setting. Recently issued international guidance on risk management and pharmacovigilance may help to improve consistency of decision-making around the world and promote better international communication and collaboration.