OBJECTIVE:To discuss how to solve patents problems in the registration and approval of drugs.METHODS:Regulations and problems in the registration and approval of drugs in China were analyzed and which were compared with that of the American and Europe.RESULTS&CONCLUSIONS:The registration and approval of drugs and their patents right protection were legally independent of each other,to which the drug administration law and patent law respectively are appli-cable.There is no necessary association between the registration and approval of drugs and the infringement of patents right.Patent dispute should be solved in accordance with the patent related regulations,the registration and approval of drugs should not involve the solving of patent disputes of drugs.

OBJECTIVE: To design an attitude scale for the investigation of the factors that influence prescribing and to promote clinical pharmacists' effective intervention on physician's prescribing behavior. METHODS: The factors influencing physicians' prescribing behaviors were investigated; using psychometric psychological measurement standards to determine the objective and contents of the attitude scale. Question types were appropriately chosen, questions were designed skillfully, and the attitude scale was pre-tested and revised. RESULT & CONCLUSION: A comprehensive, reliable and standard attitude scale is conducive to the rational use of drugs in the clinic.

OBJECTIVE:To improve response capacity of China to deal with intellectual property rights protection standard terms (Trips-plus terms) beyond the regulations of Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and to provide reference for improving national intellectual property rights protection policy. METHODS:Trips-plus terms and their common types were introduced to analyze their characteristics and consider about their adverse effects. RESULTS & CONCLU-SIONS:Common TRIPS-plus terms involve data protection,patent interlinkage,patent period extension,limitation of compulsory licensing and parallel importation,etc. These terms pose a significant challenge to developing countries,resulting in delaying entry of generics,increasing drug price,influencing drug accessibility and posing a great threat to public health. China,as the largest de-veloping country mostly relying on generic drugs,should scientifically assess the effects of TRIPS-plus on public health,drug ac-cessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement,and make effec-tive use of the TRIPS flexibility to protect the public health.

OBJECTIVE:To provide reference for perfecting the "Regulation of Drug Price Difference" issued by National Development and Reform Commission.METHODS:To review the drug price management course in China,analyze the effects and limitations since the initiation of "Regulation of Drug Price Difference" in 12 hospitals in Beijing and put forward suggestions for its improvement.RESULTS & CONCLUSIONS:"Regulation of Drug Price Difference" has contributed to the formation of unified and standard evaluation criterion and computation method or even the holistic evaluation system in drug pricing management,the lowering of the costs of human factors and administrative management in drug price management and the improvement of the governmental pricing efficiency.However,efforts should be taken to improve the unreasonable drug price difference coefficient and computation method and so on.

By analyzing relevant documents of procurement of drugs with target quantity in Shanghai, com-bined with onsite investigations and interviews, this paper summarizes the practice of procurement of drugs with target quantity in Shanghai from six aspects, namely the basic situation of centralized procurement, pilot scope and variety of procurement of drugs with target quantity, business qualification and certification, determination of successful bid-der, drug distribution, and drug payment settlement. This paper argues that Shanghai has successfully implemented the policy of procurement of drugs with target quantity, by scientifically establishing a comprehensive evaluation index of quality, setting up private drug procurement accounts, prepaying drug procurement loans and strengthening plat-form services and regulatory capabilities, in order to effectively guarantee the operation of procurement of drugs with target quantity. From this case study of Shanghai, it can draw the following implications that in order to successfully achieve procurement of drugs with target quantity mechanism, setting up functional departments of unified authority is the most important guarantee, and using technical means and platform building is the basic conditions. Therefore, the setting up of economic and technical bidding should focus on the individual properties of generic drugs, and the pro-moting of tripartite system reform will help to further expand the scope of procurement of drugs with target quantity.

OBJECTIVE:To provide reference for improving the drug price regulation policy in China. METHODS:Literature research,system comparison and other methods were used to summarize the commonalities and characteristics of drug price regula-tion policy in Germany,Japan and Taiwan area of China,and the successful experience was learned. RESULTS & CONCLU-SIONS:Drug price management in Germany,Japan and Taiwan area of China has their own characteristics. Germany conducted reference price system and new drug pricing mechanism,which was the first country to introduce the reference price system. Japan granted price premiums to innovative drugs,decreased pricing for generic drugs and adjusted drug price again. And Taiwan area of China classified and grouped differential pricing to encourage competition negotiation and regularly investigated drug prices and pric-ing. Germany,Japan and Taiwan area regard medicare pay price as core of drug price management,adopt comprehensive means to regulate the drug price,and pay attention to the monitoring and regular adjustment of market price as well. Price negotiation,phar-macoeconomics and multiple pricing methods are broadly used. Value-based drug pricing system is new trend of price policy re-form. It can be used for reference to improve the drug price regulation system in China.

OBJECTIVE:To provide reference for the establishment of a system of expired medicine recycling in China. METHODS:The experience of developed countries with respect to the system of expired medicine recycling was summed up,and the existing problems about the recycling of expired medicines in China were considered to make suggestions to the establishment of a system of medicine recycling in China. RESULTS & CONCLUSIONS:Generally,the developed countries such as Britain, France,Germany and America treat expired medicines as hazardous wastes in the Environmental Protection Law,Waste Disposal Law and other laws,and have basically standardized the recycling of expired medicines. The projects of recycling expired medi-cines in those countries are usually funded by their governments or enterprises of manufacturing or selling medicines,where the medicines were recycled at designated places or on a regular basis or by post,executed by pharmacists and pharmacies,and then disposed on the basis of classification or burned and buried at dumps. However,currently there are no laws and regulations and spe-cial funds for medicine recycling in China,leading to people’s lacking of enthusiasm to recycle the expired medicines. It is suggest-ed that China should take such measures as soon as possible,including establishing and improving the laws and regulations of ex-pired medicine recycling,distinguishing the reasonably determination and disposition of different types of expired medicines,accel-erating the reform of the medical insurance payment system,giving full play to the pharmacist’s role of medication guidance,and fully increasing information transparency.

OBJECTIVE:To provide reference for the management of re-use of single-use devices (SUDs) in China. METH-ODS:The management situation of SUDs use in China and the management policy of SUDs re-use in America and Germany were introduced,the published literature of SUDs re-use was researched and the safety and ethicality were analyzed and discussed. RE-SULTS:China had no regulation for the clear definition of the range,standards and requirements of SUDs re-use;America and Germany had well-management for the SUDs re-use with different modes. Literature analysis showed that there were 3 results for the SUDs re-use,including supporting,opposition and classified management. In terms of safety,SUDs re-use needs the base of specific species and disinfection operations;in terms of ethicality,SUDs re-use should focus on the right to know of patients and the effects on cost savings and environment. CONCLUSIONS:China should establish and improve the management policy of SUDs re-use,develop the classification assessment of re-use,encourage third-party organizations participating in the recycling of SUDs and strengthen the monitoring of adverse reactions,etc.

OBJECTIVE:To systematically review the efficacy and safety of Calf spleen extract injection combined with chemo-therapy in the treatment of cancer,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from Co-chrane Library,PubMed,Medline,EMBase,CJFD,Wanfang and VIP Database,randomized controlled trials(RCT)of the effica-cy and safety about Calf spleen extract injection combined with chemotherapy in the treatment of cancer were collected. Meta-analy-sis was performed by using Rev Man 5.0 software after data extract and quality evaluation by Cochrane 5.0. RESULTS:Totally 23 RCT were enrolled,including 1 682 patients. Results of Meta-analysis showed Calf spleen extract injection combined with chemo-therapy in the treatment of cancer can significantly improve the effective rate [OR=2.17,95%CI(1.68,2.81),P<0.001] and im-provement rate of life quality [OR=4.26,95%CI(2.47,7.32),P<0.001] and also reduce the degree rate of WBC and PLT,the inci-dence rate of nausea and emesis,the differences were statistically significant. CONCLUSIONS:Calf spleen extraction injection combined with chemotherapy has good efficacy and safety in the treatment of cancer.

OBJECTIVE:To study the development and status quo of narcotics and psychotropic substances (NPS) in China since 1949,and to provide evidence for perfection of NPS control work in China. METHODS:The development and status quo of controlled substances control by China since 1949 were summarized and analyzed through retrieving and collecting literatures,re-ports and policies about NPS from domestic and foreign databases,news reports and related website. RESULTS & CONCLU-SIONS:Chinese narcotics and psychotropic substances control dated back to the release of Interim Regulations on Narcotics Con-trol in 1950 and Regulations on Narcotics Control,Drug Administration Law and other regulations have been issued. It had experi-enced the progress from no legal basis to having laws to follow and from executive-leading to legalization. Narcotics and psychotro-pic substances were gradually unified in systematic control,and the level of regulations rised from department rules to administra-tion regulation. At present,with Regulations on Narcotics and Psychotropic Drugs Control (2005) as regulatory basis and cata-logue of narcotics and psychotropic substances(2013)as object,China Food and Drug Administration are in charge of the national regulation,cooperating with health department,agricultural department,traffic department and other departments.