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.
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the effect of internal urethrotomy with Super-impulse plasma electrode (SIPE) method on urethral stricture.</p><p><b>METHODS</b>A total of 48 patients clinically diagnosed as having urethral stricture were hospitalized and treated with SIPE under the endoscope from February 2005 to August 2006. The patients' symptoms and clinical signs were compared before and after the treatment. In addition, techniques in operating SIPE were discussed.</p><p><b>RESULTS</b>Of the 48 patients, 46 were cured and 2 experienced recurrence after the operation. A 3-18 months follow-up revealed no complications.</p><p><b>CONCLUSION</b>SIPE under the endoscope is safe and effective in the treatment of urethra stenosis. It is easy to handle and the results are satisfactory.</p>