Research on establishing the procedure of drug marketing authorization transfer based on reform of the drug review / 中国药学杂志

ABSTRACT

OBJECTIVE: To put forward several suggestions on designing procedure of authorization transfer in marketing authorization system. METHODS: Domestic and foreign regulations and articles were searched. The elements and procedures of marketing authorization transfer in America, Europe and Japan were analyzed. RESULTS: Marketing authorization transfer should be reviewed in Europe. In America and Japan, the transfer will not be reviewed, America requires the two sides of transfer to submit some information while Japan requires the transferee submit transfer notifications. These three managements all focus the transfer time of marketing authorization holder' responsibility, transferee's commitment of undertaking responsibility and the transfer of related documents. CONCLUSION: When design the procedure of marketing authorization transfer, the transfer essence should be catched, and a brief review should be conducted. Moreover, before and during the procedure, there should be some in-time communications between CFDA and two sides of transfer.