RESUMEN
OBJECTIVE: To provide the basis of improving drug importation registration management system of our country by studying domestic and foreign drug importation management system adequately. METHODS: Checked out and studied the laws associated with import drug of our country and United States with literature research and comparative analysis methods. RESULTS: To reform the drug importation registration management system of our country, related problems should be analyzed. Also the recommendations should be put forward, including the registration of foreign drug establishment, unified registration procedures and adopted DMF system. CONCLUSION: Based on national conditions, we must draw on the advantages of United States system selectively, to improve our system, ensure the quality of import drug lifecycle and protect public health.