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 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.

OBJECTIVE:To provide suggestions for constructing and improving national essential drug policy METHODS:With the introduction of the elements of national essential drug policy,the weak links in national essential drug policy promotion in China were analyzed RESULTS & CONCLUSION:The practice of the national essential drug policy was in fact still in preliminary stage,so that the state departments and different social quarters should take positive steps to promote our essential drug policy

OBJECTIVE:To explore the reason for the "tragedy of anti-commons" in biomedical patent and its effect on the development of biomedical industry.METHODS:The mathematical models of "commons" and "anti-commons" gambling were established based on the analysis on emergence of "patent bush" resulted from the abuse of biomedical patents,and the profit conflict of the patents power related to elementary researcher and applicant researcher was analyzed.RESULTS:The potential "tragedy of anti-commons" affects the enthusiasm of the biomedical researchers,hinders the rapid development of biomedical industry and the improvement of technological level.CONCLUSIONS:The corresponding measures should be taken from aspects such as system,research model,and patent applicant model to balance the possessiveness and exclusiveness,avoid the "tragedy of anti-commons" and facilitate the development of biomedical industry.

This paper analyzes the reform backgrounds, mechanisms and measures of financing and payment taken in the second-generation national health insurance (NHI) in Taiwan. The results indicate that in 2nd NHI, the rate was adjusted more flexibly, supplementary insurance premium was charged to enlarge the financial source by im-plicating additional subsidies and expanding the sources of financing, multiple payment methods and auxiliary assis-tive means were used to control the growth of medical expenses, social insurance payments are specified in terms of category or clear payment projects and standards, new health technology assessments are used as new basis for deci-sion making, etc. by greatly alleviating the financial deficit, which helped achieve the financial balance again. Many features of the 2nd NHI in Taiwan, especially like its diversified financial resources and financing methods, global budget of control fees and DRGs payment systems, making evaluation criteria for medical quality control and health insurance reimbursement project development and so on, are worth learning for the mainland China.

0.05). Compared with the sham operative group, NO content in model group was obviously lower( P

OBJECTIVE: To provide reference for the prevention of authority dissimilation of drug registration.METHODS: The economic model concerning drug registration was constructed with principal-agent theory.RESULTS: The occurrence of authority dissimilation of drug registration could be cut down by reducing public monitoring costs,improving the rate of prosecution and increasing the costs for dealing with moral risks.CONCLUSION: The authority dissimilation could be effectively prevented by balancing authority for drug registration,improving transparency of drug registration and supervisory system.

Objective To further investigate the pathohistology of chronic gastritis in children and the relationship between helicobacter pylori(Hp) infection and mucosal chronic inflammatory.Methods Gastric antrum biopsies were carried out from children who had chronic gastritis confirmed by gastroendoscopy during the past 3 years in our hospital.The results of pathohistological observation were analyzed by retrospectire method.Results One thousand six hundred cases of chronic gastritis were included,in which 1007 cases without Hp infection,593 with Hp infection.Among the patients without Hp infection,mild inflammatory were much more than mode-(rate) or severe inflammatory(86% vs 14%).Although,in patients with Hp infection,mild inflammatory were the most common presentation(63%),moderate and severe inflammatory were more predominant in patients with Hp infection.The degree of inflammatory was increased with the quantity of Hp infection.The ratio of lymphocytes,neutrophils and lymphoid follicles in gastric mucosa was much higher in Hp positive group than negative one(94%,40%,22% vs 60%,11%,5%,respectively),and the difference was significant in statistic analysis.Gastric mucosal atrophy was found more in Hp positive group(16.5%) than negative one(7%).The proportion of intestinal metaplasia in cases with Hp infection was 1.5% compared with 0.1% in these children.Conclusion The study shows that there is a close relationship between Hp and antrun chronic inflammation and mucosal atrophy.

Objective To investigate the intervention ways of endoscopes in the treatment of esophagus stenosis due to carcinoma of esophagus and improvement of quality. Method 11 cases of advanced carcinoma of esophagus were included in this study. Operation and chemical therapy were unavailable for these patients. Memory trestle with membrane and made of alloy of Nickel－ titanium was inserted under intervention of endoscope. Trestle was posed in stenosis part of esophagus under direction of X－ ray. Trestle could be dilated 3－ 7 days after operation due to its reaction characteristics to temperature. So, redilated therapy was unnecessary. Trestle could reconstruct swallowing tract and made feeding through mouth become available during limited survival time.Results All trestles were successfully inserted.Half－ fluid feeding was available after operation. Obstruction was removed in all patients(100％ ).Conclusion Method described in this study was safe and effective .Effective swallowing tracts were reconstructed in all patients after trestle was planted and quality of life and survival time were both improved.

In the middle of 1990 s, it was discovered that sirolimus had inhibitory effect on the proliferation of T lymphocytes , therefore, it is used for the treatment of anti-tumor cells.At present, the dosage forms of sirolimus are capsules , oral liquid and tab-lets.However, because of good fat-soluble and poor water-soluble property, its bioavailability is low with many side reactions .In order to provide reference for the further studies of sirolimus , the literatures in recent years were searched in Pubmed , Springer, CJFD,VIP Chinese periodical database and Wanfang data , and the research progress in the new dosage forms of sirolimus was summarized .