OBJECTIVE:To explore the supervision of internet drugstore in China.METHODS:Supervision of internet dru gstore in USA was introduced,and the nature of this supervision was analyzed.RESULTS&CONCLUSIONS:On the premise of protecting consumer rights,the internet drugstore in China should be developed and regulated gradually.

The transient period of 7 years which is regulated in 2004/24/EC Director is due to 2011. This paper discussed the changing of traditional herbal drug regulation, the increasing of herbal monographs and lists, extending the scope of the simplified registration procedure in European Union. The purpose was to promote traditional Chinese medicine to enter the market.

Objective: To provide policy recommendations for improving price negotiation system of patented drugs in China. Methods: This paper comparatively analyzes the commonalities and characteristics between Korea’ and Germany’s price negotiation models for patented drugs from three aspects of their goals, procedures and effects. Results:The key objective of both Korea’ and Germany’s price negotiation systems for patented drugs is to efficiently improve the utilization of national health insurance services, and responsibilities are properly assigned among differ-ent institutions to ensure the equity and efficiency of negotiations. However, due to the differences in national cir-cumstances, there is a big difference in the selection of technical assessment criteria. Conclusion: This paper sug-gests China to strengthen the convergence between price negotiations for patented drugs and medical insurance reim-bursement policy, to establish a technical assessment system with the innovation extent for patented drugs as its core, and to develop scientific and rational negotiation procedures and division of responsibilities as well.

The main intention of this paper is to propose suggestions for optimizing China 's high-value medical consumables centralized procurement .In this paper , we have analyzed the developed countries 'best practices in high-value medical consumables procurement from the perspectives of procurement principle ( s), key procurement bodies, procurement patterns, supervision, and management.The results of our analysis show that “Value for mon-ey” is the core principle in procurement and hospital route , national/regional centralized route ( s) , and group pur-chase organization ( GPO) route are four primary procurement patterns in foreign countries .Procurement management is optimized through improving product coding system and encouraging health technology assessment ( HTA) and clin-ical practitioners'involvement in procurement decision-making.In that perspective, it's been suggested that China's high-value medical consumables centralized procurement could be improved from three aspects:referring partial HTA indicators so as to enhance tender evaluation and realize value-based purchasing;establishing a standard and unified coding system for medical devices;introducing GPO route and make market surveillance mechanism into full play .

OBJECTIVE:To perfect public participation system of food and drug safety in China and establish“society multi-governance”of food and drug safety. METHODS:The problems of public participation in food and drug safety administration were analyzed in China. Referring to the experience of USA,Japan,South Korea and other developed countries in stage of food and drug safety legislative decision-making,regulation and enforcement and dispute settlement,the countermeasures were put forward to perfect public participation system of food and drug safety. RESULTS & CONCLUSIONS:The public is in a passive position and shows weak right of speech in legislative decision-making stage;the public is not active and shows weak awareness of partici-pating in management in regulation and enforcement stage;public interest litigation system in dispute settlement stage has not been established. Those problems impede the generation of“society multi-governance”of food and drug safety in China. In United States,Japan,South Korea and other developed countries,the position and right of the public participation can be guaranteed com-pletely through establishing complete legal system,strengthening government information transparency,improving complaints sys-tem and public interest litigation system,etc. Our country can perfect the system of public participation in the food and drug safety and promote the generation of“society multi-governance”of food and drug safety by detailing the regulations in legislative deci-sion-making,emphasizing the information opening and feedback,strengthening the propaganda of public responsibility conscious-ness,setting up scientific food and drug safety complaint and reparting system and establishing public interest litigation system.

Objective:To suggest approaches for the establishment of Chinese standards for defining rare disea-ses and advance corresponding Chinese legislation. Methods:By comparing the standards for defining rare diseases in Europe, the United States, and other countries and studying key influencing factors of standards, this paper proposes suggestions for the establishment of proper Chinese standards for defining rare. Results and Conclusion:Social and e-conomic development levels, medical development levels and social security levels influence the establishment of standards. It is recommended that the national conditions should be taken into consideration and the number of pa-tients, severity of the diseases and economic indicators of orphan drugs be used to define rare diseases in China.

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 approaches for further development of pharmaceutical care in retail drugstores by strengthening drug administration. METHODS: The main problems occurred in pharmaceutical care were analyzed from the perspective of drug administration. RESULTS & CONCLUSIONS: The main problems occurred in pharmaceutical care were the absence of laws and regulations related to pharmaceutical care,misalignment between the access criteria for retail pharmacy and the necessary conditions for pharmaceutical care. The development of pharmaceutical care could be promoted by perfecting current law system,enhancing the access criteria for running retail drugstore,and strengthening drug administration etc.

Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.