OBJECTIVE:To provide reference for Chinese pharmaceutical manufacturing enterprises to better understand and reasonable utilize the pharmaceutical administrative protection.METHODS:The essence and connotation of pharmaceutical administrative protection were defined by analyzing its origin,development and the regulations;and its role,shortcomings and future development were analyzed.RESULTS & CONCLUSIONS:Pharmaceutical administrative protection is a key part of pharmaceutical intellectual property protection system and plays a very important role in protecting pharmaceutical intellectual property and promoting the development of pharmaceutical industry.Yet it remains to be further improved in view of its shortcomings.

OBJECTIVE:To improve the level of patent protection of traditional Chinese medicine in China.METHODS:Analysis was made on the reasons for the lag of patent protection of traditional Chinese medicine on the basis of its current situation.RESULTS&CONCLUSION:The current Patent Law in China is unfit for the technical features of traditional Chinese medicine,and therefore hinders the patent protection.It is suggested that special regulations should be made for patent protection of traditional Chinese medicine.

OBJECTIVE:To discuss the routes for research and development of traditional Chinese medicine.METH?ODS:Comparative and multi-phase thinking methods were used to analyze the difference and commonness between tradi?tional Chinese medicine and Western medicine,then the research and development goals and routes of traditional Chinese medicine were established.RESULTS&CONCLUSION:Research and development of tradition Chinese Medicine should be carried forward on the basis of"tradition",that is modern methods combined with traditional theories,or modern methods combined with modern theories.In other words,the same goal can be achieved by different routes.

OBJECTIVE:To make sure who is liable for Adverse Drug Reactions(ADRs)and what kind of legal obligation should they bear and how to bear.METHODS:The concerned laws and regulations were studied by literature research method and comparative study method.RESULTS:The legal obligations involved in ADRs were tort liability and administrative liability.The obligation attribution principles were different.The fault principle should be applied to the unpredicted“develop_ mental danger”of drugs.CONCLUSION:The compensatory and relieving acts related to ADRs damages should be formulated in China.

OBJECTIVE:To provide references for China in the formulation of international marketing strategy of tradi?tional Chinese medicine(TCM).METHODS:Related literatures were referred to and the current international marketing con?cepts of Chinese traditional medicine in China were analyzed.RESULTS&CONCLUSION:The internationalized target market for TCM is indefinite,the international market demand is unknown,the propaganda is without a definite aim,and the language platform for international academic communication is insufficient.It is suggested that the target market for TCM should aimed at general nursing,chronic and stubborn diseases,the efficacy and safety of TCM should be verified by control experiment and cost-effectiveness analysis,the international communication abilities of TCM and its practitioners should be improved so as to facilitate the internalization of TCM.

Objective To evaluated the value of hysteroscopy and dilatation and curettage (DC) in diagnosis of endometrial cancer. Methods This retrospective analysis included clinical pathologic data of 3 676 patients with endometrial cancer from Jan. 1, 2000 to Dec. 31, 2010 in hospitals of endometrial cancer prevention projects in Guangdong Province. Results A total of 3 676 patients with endometrial cancer were divided into DC group (3 211 patients) and hysteroscopy group (465 patients). Compared to the results of pathological diagnosis, the accuracy rate between DC group and in hysteroscopy group were no statistically difference was 91.00%(2 922/3 211) vs 90.75%(422/465;χ2=0.030, P=0.862). The accuracy rate, sensitivity, specificity, positive predictive value and negative predictive value of cervical involvement between DC group and hysteroscopy group were 81.28%vs 86.45%(P<0.01), 24.78%vs 23.68%(P>0.05), 93.76%vs 98.71%(P<0.01),46.75%vs 78.26%(P<0.01) and 84.95%vs 86.88%(P>0.05), respectively. Rate of positive peritoneal cytology in DC group was 4.76%(153/3 211), and the rate was 3.23%(15/465) in hysteroscopy group, which were no statistically difference (χ2=2.206, P=0.137). There were no statistically difference in 5-year overall survival (91.02% vs 92.03%;χ2=0.033, P=0.856) and 5-year progression-free survival (89.81%vs 91.83%;χ2=1.508, P=0.219) between DC group and hysteroscopy group. Conclusions Hysteroscopy and dilatation and curettage is an effective method in diagnosis of endometrial cancer, especially hysteroscopy is better in diagnosis of cervical involvement. Hysteroscopy don′t improve risks of positive peritoneal cytology and don′t affect the prognosis of patients with endometrial cancer.

OBJECTIVE:To evaluate the relations between patent system and drug price under TRIPS(trade related intellectual property system).METHODS:The impact of patent protection on drug price in less developed countries,developing countries and developed countries,and the related measures taken against unfavorable prices under the TRIPS system and their advantages and disadvantages were analyzed.RESULTS &CONCLUSIONS:Patent protection did result in the increase of pharmaceutical price to some degree.The related measures such as compulsory licensing and parallel imports under the TRIPS system contributed to the decrease of the influence of patent protection over drug price,but by which the contradiction between patent system and drug prices can't be solved in the long run,futher exploration needs to be done to solve this problem radically.

OBJECTIVE:To provide reference for the enactment of policies related to pediatric drug development in China.METHODS:The pediatric drug policies of the USA and its impact were studied comprehensively.RESULTS & CONCLUSIONS:The enforcement and stimulation policies were adopted in US for pediatric drug development,which achieved certain efficacy.China might as well draw the successful experiences from US to establish policies tailored to the status of pediatric drug development in order to promote pediatric drug development and improve the health level of Chinese children.

Objective To explore the reason of low incidence of neonatal GBS infection in China. Methods The serum level of GBS type III specific antibody in 102 randomly selected prenatal mother and their neonatal cord blood were measured using ELISA method. Sixty-two neonates less than 7 days old and 32 children between 2 months and 13 years old served as control. Results The average level of GBS type III specific antibody in the mother was 21.59 mg/L, and that in the paired cord serum was 17.90 mg/L, which was correlate with their mother(r=0.83,P