OBJECTIVE： To discuss the severe challanges confronted by pharmaceutical business of China after WTO entry.METHODS： Starting with the current situation of pharmaceutical business of China， we analysed the influence exerted by the entry of foreign merchants or foreign captial into our pharmaceutical business.RESULTS ＆ CONCLUSION： In the near future， WTO entry will certainly produce a great impact on pharmaceutical business of China and will affect its survival and development in the extensive and intensive competition of international marketing.We should be fully aware of the situation that we confront with and consider countermeasure at an early date.

OBJECTIVE:To objectively look upon and analyse the influence of WTO entry on wholesale and retail of Chinese pharmaceutical businessMETHODS:Using comparative method,the influence of WTO entry was analysed concerning wholesale and retail of drugs,economically developed and developing districts,psychological and practical pressureRESULTS & CONCLUSION:Based on the analytic results,Chinese pharmaceutical business should avoid pell-mell development,enhance confidence,actively deal with the impact and seize the opportunity to seek to live on and to develop

OBJECTIVE:To further perfect our Pharmaceutical Administration Law of PRC.METHODS:Contractive methods were used to analyze comparatively the legal liabilities in US FDCA and Pharmaceutical Administration Law of PRC with regard to awarding system for reporters,penalty terms and the disposition of the confiscated drugs.RESULTS&CON?CLUSION:Compared with the PRC Pharmaceutical Administration Law,the US FDCA is more comprehensive and more consummate.We should follow the legislative spirit in FDCA and take it as a reference to improve our Pharmaceutical Ad?ministration Law.

OBJECTIVE:To provide references for the establishment of drug recall system in China.METHODS: The drug recall system in U.S.A. was introduced so as to get some enlightenment for the drug safety in China.RESULTS & CONCLUSION: We could use the drug recall system in U.S.A. for references to improve our law criterion system and carry out drug recall system on a large scale.

Objective:To provide some suggestions for improving the pharmaceutical advertisement supervision system and standardizing the pharmaceutical advertisement market. Methods: Literature reviews, statistical analysis and interviews were adopted to study the status quo and difficulties of pharmaceutical advertisement supervision and pharmaceutical advertisement trends. Results:The top-level design of pharmaceutical advertisements supervision sys-tem has two defects:the separation between approval and penalty and the obstacles to cooperation at all levels of the drug administration. The worsening status quo of illegal drug advertising has elicited concern from scholars and regu-lators. However, there are still some difficulties in the supervision of drug advertisers, advertising agents, and pub-lishers. Conclusion:It is suggested that the drug advertising regulation system should be perfected by strengthening information supervision, establishing a coordination mechanism and consolidating self-discipline consciousness. Addi-tionally, laws and regulations should be promptly revised as an essential way to improve the effects of supervision.

In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

The paper summarizes the background, development history and current state of good review prac-tice ( GRP) in the United States of America. On this basis, the paper then focuses on measures for the realization of GRP policy objective and introduces the effects of GRP by using the statistical data of the median time to application approval and approval rates of New drug applications( NDAs) and Biological License Applications( BLAs) on the first cycle. Through research, the paper considers a set of scientific and comprehensive GRP that can effectively guarantee the quality of drug reviews and improve the efficiency of drug reviews. However, China’s GRP is not complete yet. So it also suggests that improving GRP in China further by detailing the timeline of drug review in China, developing workable review templates, emphasizing training and the continuous improvement of GRP.

OBJECTIVE:To facilitate healthy development of Chinese medical industry’s original equipment manufacture(OEM).METHODS:In view of the macro-and micro-environments in China,the new tendency of Chinese medical in?dustry’s OEM and its practical importance were discussed.RESULTS&CONCLUSION:The government should evolve laws and regulations to create satisfactory macro-environment;meanwhile,enterprises should strengthen inner management to find a practical way tailored to their own development.

OBJECTIVE:To discuss the laws applicable to the behavior of“drug handling beyond limits”.METHODS:The concerned contents of the related laws,codes,administrative rules and regulations issued at different time were analyzed comparatively.RESULTS:Under different laws and regulations,the same illegal behavior had different qualitations and treatments.CONCLUSION:Under the current laws and regulations,the behavior of“drug handling beyond limits”was qualitatively regarded as“drug handling without license”remains to be further consulted.

Objective To study the application of ABCD3-I score in predicting the risk of early is-chemic stoke after transient ischemic attack (TIA) .Methods One hundred and eighty-two carotid TIA patients were divided into low risk group (n=40) ,moderate risk group (n=74)and high risk group (n=68) according to their ABCD2 ,ABCD3 and ABCD3-I scores .The incidence of ischemic stroke was observed within 7 days after TIA .Results The area under the ROC curve for ischemic stroke within 7 days after TIA was 0 .625 ,0 .713 and 0 .831 ,respectively .Twenty-seven patients (14 .8% ) developed ischemic stroke within 7 days after TIA .The incidence of ischemic stroke was significantly higher in moderate and high risk groups than in low risk group and in high risk group than in moderate risk group (6 .8% vs 0% ,32 .4% vs 0% ,32 .4% vs 6 .8% ,P< 0 .01) .The ABCD3-I socre was positively related with the incidence of ischemic stroke within 7 days after TIA (r=0 .486 ,P<0 .01) ,suggesting that ABCD3-I socre could significantly affect the incidence of ischemic stroke within 7 days after TIA (P<0 .05) .Conclusion ABCD3-I score can effectively predict the risk of early ischemic stroke after TIA ,and can thus be used in assessment and treat-ment of T IA .