OBJECTIVE To analyse current availability of pediatric drugs in China quantitatively and provide fundamental data support for optimizing the incentive policy. METHODS Based on national drug coding database issued by National Medical Products Administration, the marketed drugs were classified into children's only drug, adult-children's drug, children's inferred drug and non-children's drug by consulting the drug instructions through the approval number. Taking children's only drug and adult-children's drug as the key subjects, this paper carried out statistics and analysis on the marketing status of pediatric drugs in China from the perspectives of approval, variety, dosage form, specification, distribution of treatment fields, enterprise and so on. RESULTS Among the marketed drugs, there were 4 229 approvals for pediatric drugs and 44 112 approvals for adult-children's drugs, accounting for 2.99% and 31.19% respectively. children's only drug had 625 varieties, accounting for 18.83% of the total pediatric drug varieties. Analgesic, antipyretic, anti-inflammatory, anti-rheumatic and anti-gout drugs accounted for 55.71% of the total approvals for children's only drug(chemicals and biologics, excluding vaccines), and expectorant, antitussive and antiasthmatic agents accounted for 26.71% of total approvals for children's only drug (traditional Chinese medicine), but there were 16 and 19 treatment fields respectively were <1.00%; among the oral dosage forms, oral liquid accounted for 21.46%, while tablet, capsule, pill and other oral solid accounted for 37.51%. In the last 10 years of domestic drugs on the market, the number of approvals for regulation of water, electrolytes and acid-base balance drugs, analgesic, antipyretic, anti-inflammatory, anti-rheumatic, anti-gout drugs and respiratory drugs accounted for 64.29% of children's only drug(chemicals and biologics, excluding vaccines), the number of approvals for internal medicine-expectorant, antitussive, antiasthmatic agent, exterior-relieving agent and heat-clearing agent accounted for 61.70% of children's only drug(traditional Chinese medicine). CONCLUSION There has been a certain basis for the marketing of pediatric drugs in China, but children's only drugs are few overall. The availability of pediatric drugs varies significantly among treatment fields. Some fields are in short supply, while others are in excess supply. Most fields are difficult to meet the drug demand of children, and the R&D and production of children's only drug is still concentrated on traditionally strong fields.

OBJECTIVE To clarify the institutional logics of the dilemma of the use of national medical insurance negotiation drugs（referred to as “national negotiation drugs”）， and promote the implementation and use of these drugs in medical institutions. METHODS Based on the complex institutional environment in which medical institutions were situated， the theory of multiple institutional logics was used to construct an analytical framework for the behavioral choices of medical institutions， and reveal the mechanism of the difficulty in the use of national negotiation drugs by clarifying the interaction and conflict of multiple logics in this process， so as to put forward some measures. RESULTS & CONCLUSIONS There were contradictions and coupling among the state logic， market logic， social logic and professional logic in the use of national negotiation drugs. In the game of multiple logics， the market logic and professional logic tended to be risk-averse， the failed “pressure-type system” of state logic， and the social logic was weakened， which caused the lack of action in the use of national negotiation drugs with the goal of completing performance evaluations in the current medical institutions. Thus， it is suggested to unbundle the invisible policy restrictions on the use of national negotiation drugs， form the pressure and motivation of medical institutions by incentive and constraint mechanisms， respond to the clinical demand by establishing a green procurement channel， and construct the supervision mechanism on the use of national negotiation drugs by social force， etc.， so as to enhance the effect of the national negotiation drugs.

Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.

OBJECTIVE To analyze the public participation mechanism of National Institute for Health and Care Excellence （NICE） health technology assessment in England and to provide experience for the dynamic adjustment of Chinese medical insurance catalog. METHODS By retrieving related literature and official websites， types and mechanisms of public participation （management organization， selection method， participation mode， evaluation feedback） in NICE health technology assessment were analyzed comprehensively； and based on this， suggestions were put forward to adjust the public participation in Chinese medical insurance catalog. RESULTS & CONCLUSIONS The current public participation types of NICE health technology assessment were patient and carer organizations， HTA committee lay members， patient expert and public observers. At the management level， NICE has set up a public participation team and made guidelines on public participation matters. For different public participation types， NICE has established different selection procedures， such as expression of interest， NICE invitation， open recruitment， nomination， NICE decision， etc. The public participation types are various and in the whole assessing process from the initial determination of the scope of the health technology assessment to the final appeal. Also， NICE has established a flexible and dynamic evaluation feedback system to optimize the way of public participation and the health technology assessment process； NICE has undertaken extensive international cooperation and exchanges to promote public participation at the national and international levels. It is suggested that our country should combine the national conditions， clarify the channel of public participation in health technology evaluation， set up a working group of public participation affairs， strengthen patients’ participation in evaluation and feedback， improve decision-making transparency， and improve the public participation mechanism of health technology evaluation from the aspects of channel opening， management mechanism， evaluation feedback， information disclosure and so on.

Objective: To investigate the epidemiological characteristics of varicella in Yandu District, Yancheng City, Jiangsu Province from 2005 to 2021, so as to provide insights into the improvements of the varicella control strategy. Methods: The data pertaining to cases in Yandu District from 2005 to 2021 were captured from the National Notifiable Diseases Network Reporting System, and the coverage of varicella vaccination in Yandu District from 2016 to 2021 was captured from the Jiangsu Provincial Immunization Planning System. The trends in incidence of varicella were analyzed using annual percent change (APC), the temporal, population and spatial distributions of varicella cases were descriptively analyzed, and the correlation between the cumulative first-dose varicella vaccination rate and incidence of varicella was examined among birth cohorts in Yandu District from 2005 to 2021. Results: Totally 6 144 varicella cases were reported in Yandu District from 2005 to 2021, with annual mean reported incidence of 50.05/105. The incidence of varicella appeared a tendency towards a rise in Yandu District from 2012 to 2018, with APC of 77.97% (t=11.702, P<0.001), and the incidence appeared a tendency towards a decline from 2018 to 2021, with APC of -41.93% (t=-6.911, P<0.001). The incidence of varicella peaked during the period between November and January of the following year (45.95%), and during the period between May and June (20.35%). The mean incidence of varicella was higher among men than among women (54.72/105 vs. 45.00/105; χ2=57.858, P<0.001). The highest incidence of varicella was found among cases at ages of 6 to 9 years (543.78/105), and varicella predominantly occurred among primary school students (38.40%) and pre-school children (31.85%), with high annual mean incidence in the eastern urban areas (74.27/105).The cumulative first-dose varicella vaccination rate negatively correlated with the incidence of varicella among the birth cohorts in Yandu District in 2019 (r=-0.501, P<0.001), 2020 (r=-0.646, P<0.001) and 2021 (r=-0.602, P<0.001). Conclusions The incidence of varicella appeared a tendency towards a rise followed by a reduction in Yandu District from 2005 to 2021, and the incidence of varicella peaked in winter and at the turn from spring to summer, with varicella predominantly found among primary school students and preschool children.

Objective To construct the evaluation index system for pharmacist training effectiveness in China. Methods The initial framework of index system based on Kirkpatrick evaluation model was constructed through literature research and expert interview method. Delphi method was used to analyze the index system. Results The evaluation index system for pharmacist training effectiveness in China included 4 first-level indicators, reaction evaluation, learning evaluation, behavior evaluation and result evaluation, 9 second-level indicators, training scheme, teaching staff, training conditions, theoretical knowledge, practical skills, the change of work ability, the change of professional attitude, personal income and organizational income, as well as 32 third-level indexes such as pharmaceutical professional knowledge. Conclusion This evaluation index system for pharmacist training result is highly scientific and systematic. It covers the whole-process and follow-up evaluation of the training activities. It can optimize the pharmacist training schedule and improve the program design for the effective pharmacist training evaluation.

OBJECTIVE To provide reference for clarifying the action and development direction of China ’s drug safety governance. METHODS Based on governance theory ，an analysis framework of “Motivation-Sharing-Performance and Feedback ” was established to explain the mechanism of cross-sector collaboration governance of drug safety. By constructing the action framework of national drug safety governance of “3 stages+1 incubation period ”，the connotation of each stage and possible challenges were analyzed ，and improvement suggestions were put forward. RESULTS & CONCUSIONS The obstacles that restricted the effectiveness of drug safety governance in China were mainly due to insufficient information ，resource mobilization and power sharing. Therefore ，the“basic collaboration stage ”should expand the scope of information sharing and involve non-governmental entities ；the“legislative coordination stage ”should focuse on the provision of formal legal systems so that non-governmental forces can play a necessary role in governance activities ；the“deepening of the coordination stage ”should promote the formal integration of social forces into governance system ，and truly realize the transition from “passive participation ” to self-management. It is recommended to continuously improve the construction of drug safety governance system in China in terms of governance norms ，communication mechanisms ，capacity development based on a holistic perspective.

OBJECTIVE：To learn from pedia tric drug pricing and price incentive policy in Japan ，and to provide reference for the improvement of pediatric drug price system in China. METHODS ：The drug pricing strategy of Japan was analyzed ，and price incentive policy of pediatric drugs in Japan and its implementation status and effect were summarized. The suggestions of perfecting the price system of pediatric drugs in China were put forward . RESULTS & CONCLUSIONS ：The pricing strategy of medical insurance drugs in Japan included two types ，such as access pricing of medical insurance list and price adjustment of drugs in medical insurance list. Among them ，price incentive policy for pediatric drugs mainly included the premium for initial pricing of new pediatric drugs ，the premium for drugs with newly added pediatric indication included in medical insurance list and other measures（such as eligible drugs could obtain indirect price compensation ，and children ’s factors could be considered in health technology assessment ）. Overall ，these measures accelerated the R&D and marketing of Japanese pediatric drugs ，and effectively promoted the development of pediatric drugs in Japan. The author suggests that our country should carry out health technology assessment which reflects the particularity of pediatric drugs ，give appropriate direct price incentives to the payment price of pediatric drugs ，and reasonably set the price of drug specification suitable for children and give price incentives so as to promote the development of pediatric drugs in China.

OBJECTIVE：To provide reference for further improving the establishment of drug registration applicant compliance management organizations in China. METHODS ：Through introducing and analyzing the establishment ，responsibility configuration and operation mechanism of drug registration applicant compliance management organizations in the United States ，the suggestions were put forward for improving the establishment of drug registration applicant compliance management institutions in China. RESULTS & CONCLUSIONS ：There were two levels of compliance management organizations for drug registration applicant in the United States ；at Office of the Commissioner of FDA level ，the Compliance Policy Council was responsible for ensuring consistency in the implementation of all compliance policies in the FDA regulated area ；at the level of Center for Drug Evalution and Research （CDER）and Office of Regulatory Affairs （ORA），the compliance management function was mainly undertaken by Office of New Drugs （OND），Office of Generic Drugs （OGD），Office of Compliance （OC） and Office of Communication （OCOMM）under CDER ，as well as Office of Policy and Risk Management （OPRM），OC，Office of Bioresearch Monitoring Operations（OBIMO）and Office of Pharmaceuticl Quality Operations （OPQO）under ORA ，which were responsible for developing compliance documents and procedures ，carrying out compliance education ，compliance guidance ，compliance inspection and punishment for violations. Before submission stage of drug registration application ，the compliance education function of OC and the compliance guidance function of OND/OGD played an important role ；in the application submission stage ，OND/OGD was responsible for the compliance review of application materials ；in the stage of reviewing the application materials ，OND/OGD and OC of CDER ensured drug compliance through collaboration with OC ，OBIMO and OPQO of ORA. The establishment of drug registration compliance management institutions in China was still in the preliminary exploration stage. It is suggested that China can learn from the relevant experience of the United States ，establish a multi-level or ganization structure ，set up an independent compliance education department ， and strengthen thecooperation between evaluation department and compliance inspection department ，and to improve the level of compliance management of drug registration applicants in China.

OBJECTIVE：To provide reference for improving the supporting system of drug safety governance in China. METHODS：Through analyzing the main ways ，characteristics and effectiveness of drug safety governance in Australia ，the suggestions for building drug safety governance system in China were put forward initially. RESULTS & CONCLUSIONS ：The methods of Australia ’s drug safety governance are to conduct division of labor between the federal and state/territory governments ， advanced-voluntary-bundled-payment-model. conduct policy consultations with different related entities separately ，guide industry self-discipline based on industrial development level，and support industry to participate in drug advertising supervision. Australia ’s drug safety governance has the characteristics of large information sharing channels ，increasing the transparency of government work ，carrying out targeted education and enhancing the governance capacity of participants etc. It has achieved significant improvement in the occurrence of drug recall events，and significant increase in the satisfaction of stakeholders in the communication activities of drug regulatory authorities. In contrast，the participation consciousness and ability of relevant entities in China are still not strong ，and the system to ensure the participation of these entities is not yet sound. It is recommended that China should pay more attention to the communication between the upper and lower levels of governments ，conduct targeted education or training for principals of non-government entities， implement the policy consultation rights of non-government entities ， as well as guide self-discipline based on self-management ability of industry entities so as to initially establish drug safety governance system in China ，and enhance the governance efficiency.