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 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 .

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.

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.

OBJECTIVE :To give sonic references for improving the quality of drug use and the regulations of pharmacy in China. METHODS: In this paper. OBRA - 90 and the situation of drug use review in America are introduced and analyzed,and inadequate insurance in drug use in China is pointed out.RESULTS & CONCLUSION :The drug use review system in USA is quite successful in ensuring the safety of drug use in public, and we can learn something from it to improve the quality of medication in China.

OBJECTIVE:To discuss the role of licensed pharmacists in retail drug stores.METHODS:The current situation of licensed pharmacists’role playing in retail drug stores and the influcing factors were analysed.RESULTS&CONCLU?SION:The licensed pharmacist system remains to be perfect in China,we suggust that the licensed pharmacists'role should be further strengthed from two links,i.e.“access”and“employment”.

OBJECTIVE:To explore the way of establishing the ADR victims'relief system in our country.METHODS:To introduce the ADR victims'relief system of Japan,analyse the significance of establishment and practice of ADR victims'relief system in China.RESULTS&CONCLUSIONS:The ADR victims'relief system of our country should be established as soon as possible so as to guarantee the victims'rights.