Investigation And Research On Re-Registration Of Drugs And Present Situation Of Implementation Of New Version GSP

Both re-registration of drugs and new version GSP belong to supervision of administrative license of drugs. The former was first implemented in 2010, and many problems were met in actual work because of the imperfection of dug re-registration system. The latter was revised on the basis of old version GSP and officially implemented on June 1,2013. And the author had found many problems through participating the site authentication of new version GSP. Therefore, the objective of the subject is to provide suggestions for further perfecting re-registration of drugs and comprehensively promoting the implementation of new version GSP.The method of interview survey was used for the research of drug re-registration. The administrative staff engaged in drug re-registration approvals in different provinces were interviewed to find the problems in drug re-registration of our country. Then the method of analogy and comparison study was used to selectively draw lessons from the mature experience of the foreign developed countries in drug post-marketing surveillance. The method of questionnaire survey and data statistical analysis was used for the research of new version GSP. The cognition questionnaire survey was conducted among the staff of some drug trading enterprises in Chongqing, and meanwhile the defective items of on-site authentication from 200 drug wholesalers were counted and the items of higher frequency were analyzed.The results of expert interviews showed there were many problems in drug re-registration of our country, which mainly focused on the aspects of evincive document, various summaries and approval quality and so on. Through studying the laws and regulations of drug post-marketing surveillance in Europe and America, we found that American annual report of drug post-marketing and drug re-registration of European Union were similar to drug re-registration of our country, and their system was more perfect. Therefore, the method of analogy and comparison study was used to compare the laws of Europe and America with drug re-registration of our country, find out the similarities and differences and selectively draw lessons from the experience based on Chinese situation.Finally, the feasible suggestions which perfect drug re-registration of our country are thrown out.The cognition questionnaire results of new version GSP showed that the cognition of staff in drug wholesalers was better than retail pharmacies, but the overall level of both were low. Moreover, the training for staff with low position, low educational background and low title in drug wholesalers and retail pharmacies was insufficient. The statistic results of the defective items showed the number of clauses whose defective rate was more than 20% was 31. Except for the link of ex-warehouse and after-sales management, the other 12 chapters existed defective items easily occurred. In order to comprehensively promote the implementation of new version GSP, the drug administration needs to increase the intensity of the training of enterprises staff, and the enterprises themselves need to strengthen the training of grass-roots staff. Besides, the government needs to further perfect new version GSP, make clear and elaborate some provisions, and publish the matched appendix of quality management system as soon as possible. At the same time, the enterprises themselves need to deepen the understanding of new version GSP and establish the corresponding modified measures according to the statistic results of defective items. Furthermore, the drug administration needs to improve the operation level of authentication inspectors and perfect the management mechanism of the inspectors.