The Drug Approval Process in the U.S.,. Europe, and Japan

OBJECTIVE: To describe the formal drug approval processes in the three major pharmaceutical markets in the world, and to examine their major differences. The article discusses some marketing and economic implications of efforts to provide greater uniformity on an international basis. DATA SOURCES: Literature and Internet references, interviews with government officials. DATA SYNTHESIS: Not applicable. CONCLUSION: Efforts to bring uniformity to the regulation of the international drug industry are bringing pressure on the U.S. FDA to change, and should be supported by the world medical community.