Analysis on approval and declaration of new Chinese medicines from 2016 to 2022 / 国际中医中药杂志

Objective:To discuss and analyze the current situation of the application and approval of new Chinese medicine in China; To provide a reference for the research and development of new Chinese medicines in the future.Methods:The drug registration data were retrieved from Xanda database from January 1, 2016 to December 31, 2022, and the information of new approval and application of new Chinese medicines during this periods was systematically organized from the aspects of the number of registered varieties, registration categories, therapeutic areas, prescription sources, dosage form distribution, development cycle, clinical research and control drugs.Results:From 2016 to 2022, the total number of application for new Chinese medicines was 265. The number of registration classification 1.1 of new compound drugs was the largest. The dosage forms of new drugs were mainly granules, capsules, and tablets. Indications mainly focused on respiratory, neuropsychiatric, digestion and cardio-cerebrovascular diseases, etc. From 2016 to 2022, the total number of approval for new Chinese medicines was 29, of these, 19 from 2021 to 2022. The number of registration classification 1.1 of new Chinese medicines was the largest. The treatment fields are mainly respiratory system, gynecology and neuropsychiatric diseases, etc. The dosage forms of new drugs were mainly granules, capsules, and tablets. The number of drugs in prescriptions was 6-15. High-frequency drugs included Glycyrrhizae Radix et Rhizoma, Ephedrae Herba, Scutellariae Radix, Pinelliae Rhizoma, Poria and Gypsum Fibrosum. Phase Ⅱ and phase Ⅲ of the clinical trials had the largest number. The development period was approximately between 10-20 years. The most prescription source of new drugs was clinical experienced prescriptions and hospital pharmaceutics.Conclusion:The results show that China has been gradually building-up a relatively complete ecosystem for research and development of new Chinese medicines, helping to develop more high-quality Chinese medicines.

Analysis and research on implementation status of informed consent in surgery / 中国医学伦理学

Objective:Investigating the content and signing status of the informed consent form for surgery,as well as the signing status of the power of attorney to understand the current implementation of informed consent for surgery in medical institutions.Methods:A stratified random sampling method was used to investigate the signing status of surgical consent and power of attorney on 276 surgical records from a tertiary A hospital in the first half year of 2022.Results:The signatures of both patients and doctors were relatively complete.The medical teams had provided sufficient information to patients regarding the main preoperative diagnosis,surgical name,possible complications during or after the surgery,and surgical risks.However,there was inadequate information on the patient's own high-risk factors,as well as alternative treatment plans and their advantages and disadvantages.The signing of surgical consent and power of attorney signed by non-patients was not standardized.Conclusion:The implementation of informed consent for surgery in medical institutions is relatively good,but there are still some shortcomings.Medical institutions can ensure the implementation of informed consent by strengthening legal and regulatory training,clarifying the scope of authorization,strengthening the surgeon's notification and signing,as well as implementing supervision and inspection,so as to protect the unity of rights and obligations of doctors and patients,effectively avoid medical risks,and promote the construction of a harmonious doctor-patient relationship.

Investigation and Analysis of Pharmacovigilance Inspection of Drug Marketing Authorization Holders / 医药导报

Objective To investigate the current situation,problems and suggestions of pharmacovigilance activities conducted by drug marketing authorization holders(MAH)and pharmacovigilance inspections carried by regulatory authorities.Methods A questionnaire survey was conducted on relevant institutions and personnel responsible for pharmacovigilance inspections in 31 provinces,autonomous regions,municipalities and the Xinjiang Production and Construction Corps.The MAH pharmacovigilance activities were rated from 5 aspects(5 major items and 27 specific items).Results The average overall score for 5 major items was 3.46;The average score for 27 specific activities was 3.50.The MAH scored the highest in terms of pharmacovigilance organization,personnel,and resources,and scored the lowest in terms of drug risk identification and assessment.Conclusion MAH needs to further strengthen their awareness of primary responsibility,gradually improve the pharmacovigilance system,and constantly improve the ability and level of pharmacovigilance;The drug regulatory department should also provide guidance to enterprises,establish and improve the team of inspectors,and systematically advanced various aspects of pharmocovigilance inspection.

Estrategia regulatoria del desarrollo de Quimi-Hib®, vacuna conjugada semisintética contra Haemophilus influenzae tipo b

Introducción: Quimi-Hib®, una vacuna cubana obtenida por síntesis química y única en el mundo, requirió una estrategia regulatoria específica, porque no hay guía con las pautas requeridas para su producción y control. Objetivo: Caracterizar la estrategia regulatoria de la etapa precomercialización de Quimi-Hib® en Cuba. Material y Métodos: Estudio descriptivo-retrospectivo de requisitos para el registro sanitario de la vacuna cubana. Se establecieron siete pasos estratégicos para abarcar los estándares reguladores vigentes y futuros, con base en opiniones de expertos para la adopción de decisiones. El punto de partida fue la guía de la OMS, aplicable a vacunas anti-Hib de origen natural. Resultados: La estrategia regulatoria se desarrolló a partir de las 15 recomendaciones de esta guía, 11 de ellas se extrapolaron a la vacuna cubana y cuatro no, pero se consideraron sus fundamentos para desarrollar cuatro requerimientos aplicables a la vacuna semisintética. Se adicionaron otros seis, tres a solicitud de la Autoridad Reguladora Nacional de Cuba y tres obtenidos de la literatura relevante disponible. Estos 21 requerimientos completan el paquete regulador, resultado de la estrategia desarrollada para esta vacuna y la posterior aprobación de su registro sanitario y comercialización. Conclusiones: La estrategia regulatoria desarrollada en este trabajo permitió definir un conjunto de recomendaciones que suple la carencia de regulaciones internacionales y contribuyó a la obtención segura del registro sanitario de la vacuna Quim-Hib® que podría generalizarse a otras vacunas con características similares.

Introduction: Quimi-Hib®, a Cuban vaccine obtained by chemical synthesis and unique in the world, required its own regulatory strategy because there is no guideline on the requirements for its production and control. Objective: To characterize the regulatory strategy of the pre-launch phase of Quimi-Hib® in Cuba. Material and Methods: Descriptive-retrospective study of the requirements for the approval of the Cuban vaccine. Seven strategic steps were established to cover current and future regulatory standards based on expert advice for decision making. The starting point was the WHO´s guideline, which applies to anti-Hib vaccines of natural origin. Results: The regulatory strategy was developed based on the 15 recommendations of the aforementioned guideline, 11 of which were extrapolated to the Cuban vaccine and four of which were not, but served as the basis for the development of four requirements with similar rationale that apply to the semisynthetic vaccine. Six additional requirements were added, three of which were requested from the Cuba's National Regulatory Authority and three of which were obtained from the available relevant literature. These 21 requirements complete the regulatory package, the result of the strategy developed for this vaccine and the subsequent approval for marketing authorization and commercialization. Conclusions: The regulatory strategy compensates for the lack of specific guidelines for synthetic Haemophilus influenzae type b vaccines and thus contributed to the approval of the first vaccine of this type. The regulatory strategy is flexible because it includes update requirements throughout the vaccine life cycle, and expert consensus was considered in its development.

A qualitative study on perceptions of COVID-19 vaccine among health care worker in a rural area of West Bengal, India

Background: COVID vaccines have been rolled out all over the world after emergency use authorization in the prevailing pandemic situation. However, hesitancy about its safety and efficacy exists among beneficiaries. Vaccine hesitancy can be a barrier to adequate immunization coverage. Aims and Objectives: This qualitative study was undertaken among health care workers in the rural field practice area of a tertiary care hospital, to find out their perceptions about COVID vaccines, and reasons behind hesitancy toward the same. Materials and Methods: Six focused group discussions (FGD) were held with the help of moderator. Each FGD had five members, so 30 members were included in the study. Health care workers included doctors, nurses, ANM/ASHAs, and other health care workers. Results: There were 17 males and 13 females. Doctors had a positive attitude toward vaccination, but other health care workers had mixed perception regarding vaccination. Most grass root level workers were sceptical about the efficacy of the vaccine. Conclusion: Mostly positive attitude toward COVID vaccines was observed in the present study. Hesitancy toward vaccines was observed in some health care workers, and it likely rooted from their inadequate knowledge about the vaccine.

Analysis and Suggestions on Status Quo of Commissioned Production under Medical Device Marketing Authorization Holder System in China / 中国医疗器械杂志

OBJECTIVE@#Sort out and analyze the current status and existing problems of the pilot work of the medical device marketing authorization holder system to provide reference opinions for the full implementation of the medical device marketing authorization holder system.@*METHODS@#Use literature analysis, comparative analysis and field research to comprehensively analyze the status, advantages and risks of commissioned production under the medical device marketing authorization holder system.@*RESULTS@#The commissioned production under the medical device marketing authorization holder system brings dividends and also brings risks.@*CONCLUSIONS@#We should consider improving the medical device marketing authorization holder system from marketing authorization holder, the entrusted manufacturer, and the regulatory authority, and strengthen the quality supervision of the entrusted production of products.

O supervisor suposto saber: perspectivas lacanianas sobre a análise de controle / The supervisor supposed to know: Lacanian perspectives on control analysis / El supervisor supuesto saber: perspectivas lacanianas sobre el análisis de control / Le superviseur supposé savoir: perspectives lacaniennes concernant l'analyse de contrôle

De forma a preservar o ímpeto evolutivo e o alcance da psicanálise, a tarefa da análise de controle é prevenir o estabelecimento da inércia que busca o menor denominador comum e a degeneração de ideias e práticas em evolução na direção de banalizações e preconceitos. A uma instituição psicanalítica é necessário manter padrões mínimos e simultaneamente preservar-se como ambiente vibrante e dinâmico para o contínuo desenvolvimento e regeneração da psicanálise enquanto estrutura viva e simbólica. Através de uma análise de controle, cada analista adquire um estilo analítico único, que não se refere a preferências e idiossincrasias egoicas, mas a uma singular e nova articulação subjetiva dos elementos preexistentes na estrutura tradicional. Sem a realização de uma análise pessoal, a análise da contratransferência e da identificação projetiva em supervisão pode operar como resistência à análise pessoal, essa última o mais importante fator para a autoautorização do analista dentro da organização psicanalítica. O analista não é autorizado pela supervisão ou pelo supervisor, mas pela experiência analítica pessoal com o inconsciente, o sintoma e seus efeitos pós-analíticos sob a forma do que Lacan nomeia de sinthoma. Lacan diz que, ao término da análise, o analisando ou futuro analista não se identifica com o analista, mas sim com seu sinthoma.

The task of control analysis is to preserve the evolutionary impetus and edge of psychoanalysis and prevent the inertia towards the lowest common denominator, and the degeneration of evolved ideas and practices into common assumptions and prejudices. A psychoanalytic organization needs to maintain standards while also preserving the organization as a vibrant and dynamic site for the continuing development and re-invention of psychoanalysis as a living symbolic structure. Through a control analysis every analyst acquires a unique analytical style that does not refer to ego preferences and idiosyncrasies, but to a singular and new subjective articulation of the pre-existing elements of a traditional structure. Without a personal analysis, the analysis of the countertransference and of projective identification in supervision can function as a resistance to the personal analysis which is the most important factor for the self-authorization of the analyst within a psychoanalytic organization. The analyst is not authorized by supervision or the supervisor, but by the personal analytical experience with the unconscious, the symptom, and its post-analytical effects in the form of what Lacan calls the sinthome. Lacan said that at the end of analysis, the analysand or the future analyst does not identify with the analyst, but rather with his/her sinthome.

Con el fin de preservar el ímpetu evolutivo y el alcance del psicoanálisis, la tarea del análisis de control es evitar el establecimiento de inercias que buscan el mínimo común denominador y la degeneración de ideas y prácticas en la evolución en la dirección de trivializaciones y prejuicios. Para una institución psicoanalítica es necesario mantener estándares mínimos y simultáneamente preservarse como un entorno vibrante y dinámico para el desarrollo continuo y la regeneración del psicoanálisis como una estructura viva y simbólica. A través de un análisis de control, cada analista adquiere un estilo analítico único que no se refiere a preferencias del ego e idiosincrasias, sino a una singular y nueva articulación subjetiva de los elementos preexistentes en la estructura tradicional. Sin realizar un análisis personal, el análisis de la contratransferencia y la identificación proyectiva en la supervisión puede operar como resistencia al análisis personal, este último el factor más importante para la auto autorización del analista dentro de la organización psicoanalítica. El analista no está autorizado por la supervisión o el supervisor, sino por la experiencia analítica personal con el inconsciente, el síntoma y sus efectos posanalíticos en forma de lo que Lacan llama sinthoma. Lacan dijo que al final del análisis, el analista o analista futuro no se identifica con el analista, sino con su sinthoma.

De façon à préserver l'élan évolutif et l'étendue de la psychanalyse, la tâche de l'analyse de contrôle est celle de prévenir l'établissement de l'inertie qui cherche le plus petit dénominateur commun et la dégénération d'idées et de pratiques en évolution dans la direction des banalisations et des préjugés. Il faut qu'une institution psychanalytique maintienne des étalons minimaux et simultanément se préserver en tant qu'une ambiance vibrante et dynamique pour le développement continu et régénération de la psychanalyse considérée comme une structure vive et symbolique. Par l'intermédiaire d'une analyse de contrôle, chaque analyste acquiert un style analytique unique qui ne se réfère pas à des préférences et des idiosyncrasies égoïques, mais à une nouvelle articulation singulière et subjective des éléments préexistant dans la structure traditionnelle. Sans mener une analyse personnelle, l'analyse du contre-transfert et de l'identification projective en supervision peuvent opérer en tant que résistance à l'analyse personnelle, cette dernière le plus important élément pour l'auto autorisation de l'analyste chez l'organisation psychanalytique. L'analyste n'est pas autorisé par la supervision ou par le superviseur, mais par l'expérience analytique personnelle du surmoi, du symptôme et de ses effets postanalytiques, sous la forme de ce qui Lacan nomme sinthome. Lacan dit que, à la fin de l'analyse, l'analysant ou le futur analyste ne s'identifie pas à l'analyste, mais à son sinthome.

Mechanism Study on Risk Sharing and Transfer of Drug Marketing Authorization Holders Based on Drug Defects / 中国药房

OBJECTIVE：To explore the mechanism of risk sharing and transfer of drug marketing authorization holders （MAH）based on drug defects ，and to promote the smooth implementation of MAH system in China. METHODS ：Firstly，the types of drug defects in the whole drug life cycle were analyzed ，and then the sources and “fault party ”of different types of drug defects in the open commissioning environment of the industry chain under the MAH system were also analyzed. Based on it ，the mechanism of risk sharing and transfer of MAH was established combined with foreign experience and China ’s actual situation. RESULTS & CONCLUSIONS ：Drug defects were divided into design defects ，manufacturing & operation & storage & transportation quality defects and use defects ，among which design defects and manufacturing & operation & storage & transportation quality defects were the two most important defects. Design defects mainly included those caused by human factors and those could not be found by current level of science and technology ，the“fault party ”according to different circumstances may be both the research and development institutions and may be the MAH. The “fault party ”of production & operation & storage & transportation quality defects was the drug production & operation & storage & transportation enterprises. For design defects ，it was recommended to establish China ’s adverse drug reaction compensation mechanism through a combination of insurance and relief. For production & operation & storage & transportation quality defects ，it was recommended that the drug quality liability insurance as the main ，contractual agreement as the supplement ，so that the “fault party ”should assume due responsibility.

Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China / 中国药科大学学报

@#Drug Administration Law revised in 2019 proposed for the first time conditional marketing authorization at the legal level, marking the formal implementation of the conditional marketing authorization in China. This paper compares the regulations and technical requirements of conditional marketing authorization drugs in China with those in Europe and the United States, in an attempt to learn from the experience of chemistry, manufacture and control review of these drugs in Europe and the United States, and to discuss the pharmaceutical technical requirements of conditional marketing authorization drugs in China.

Analysis of Risk Factors of MAH Pharmacovigilance Outsourcing / 中国药房

OBJECTIVE：To analyze th e risk factors of marketing authorization holder （MAH）pharmacovigilance outsourcing and propose risk management and control strategies ， and to provide reference for MAH to successfully implement pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies. METHODS ：Based on the principal-agent theory and brainstorming method ，the risk factors were preliminarily determined ，and a questionnaire was designed. The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random sampling. The factor analysis method was used to statistically analyze the questionnaire data ，and the comprehensive risk factors and their respective factor scores were summarized. RESULTS & CONCLUSIONS ：A total of 200 questionnaires were distributed ， and 154 valid questionnaires were returned ，with effective recovery rate of 77.00％. The results of factor analysis method showed that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities ，which were service providers and outsourcing management factor （3.792 score），MAH factor （3.766 score），regulations factor （3.626 score）and market factor （3.610 score）from high to low. In view of the above factors ，it is suggested that MAH should focus on improving outsourcing contract ，establishing information communication mechanism with service providers ，strengthening auditing and management，strengthening pharmacovigilance ability and personnel building ，defining appropriate pharmacovigilance outsourcing business contents ， and fully doing pre-service investigation of service providers ， when MAH conducts outsourcing of pharmacovigilance. It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management specifications or guidelines as soon as possible and strengthen the supervision of service providers. It is suggested to try to establish a pharmacovigilance outsourcing industry associa tion， andstandardize the industry behavior by giving full play to the influence of the association ，so as to avoid the outsourcing risk.

Study on Technical Risks and Primary Responsibility of Medical Artificial Intelligence Diagnosis Products under Strategy of "Healthy China" / 中国医疗器械杂志

OBJECTIVE@#It provides reference for accurate and efficient supervision of medical artificial intelligence industry.@*METHODS@#By summarizing the main responsibility dilemma of medical artificial intelligence diagnosis products, sorting out relevant researches at home and abroad, the primary responsibility system of medical artificial intelligence diagnosis products is constructed.@*RESULTS@#A medical artificial intelligence diagnosis products primary responsibility system with the marketing authorization holder as the "first responsible person" is established, and three safeguard measures are proposed, namely, algorithm transparency and interpretability, classification supervision mode and social co-governance supervision mode.@*CONCLUSIONS@#The medical artificial intelligence diagnosis products primary responsibility system is helpful to implement the primary responsibility, to build "responsible and beneficial" artificial intelligence, and to realize "self-discipline", "good governance" and "in good order".

Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval / 中国医疗器械杂志

This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS， MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.

Consideration of antibody drug conjugates development and regulation / 药学学报

Antibody drug conjugates (ADCs), as they combine the targetability of monoclonal antibody and cytotoxicity of small molecules, are a growing class of therapeutics for cancer. The key factor of ADCs development is the accurate selection of parameters including tumor target, monoclonal antibody, cytotoxic payload, and linkage strategy of antibody to payload. Here, we summarize the main elements in the structural design and the development of ADCs, as well as the regulatory consideration of product manufacturing and control, which would be helpful for the research and development of ADCs.

Comparative Study on the Current Situation of Pharmacovigilance in Pharmaceutical Manufacturers of Different Scales in Jiangsu Province / 中国药房

OBJECTIVE：To study the current situation of pharmacovigilance work in large ，medium and small-scale pharmaceutical manufacturers in Jiangsu Province ，and to provide reference for the pharmacovigilance development of drug manufacturers with different scales. METHODS ：The situation of pharmacovigilance work in 108 manufacturers in Jiangsu province was investigated through a questionnaire survey and related websites. The pharmacovigilance work （organization，personnel and training，document，computer system ），drug safety monitoring （case report ，regular safety update report ，post-marketing safety research） and drug risk management （signal management ， risk management plan ， risk control measures ， drug safety communication）of different manufacturers were investigated to put forward the suggestions. RESULTS & CONCLUSIONS ：There was no significant difference in the organizational structure （independently established specialized agencies ）among manufacturers of different scales （P＝0.60）. Most of the manufacturers had less than 50％ of the proportion in the independent establishment of specialized institutions for pharmacovigilance. There was significant difference in personnel and training （situation and number of full-time staff in charge ，medical and clinical pharmacy personnel number ），document（formulating training management system ， entrusted management and key monitoring procedures ），computer system （P＜0.05）. There was no difference in the main collection ways of case reports among manufacturers of different scales ；however，the number of independent reports in 2019（P＜ 0.01），the proportion of quality control process for regular safety update reports （P＝0.01），and the proportion of carrying out post-marketing safety research in recent five years （P＜0.01）in large-scale manufacturers were all significantly higher than small- and medium-scale manufacturers. The proportions of large-scale manufacturers （70.00％） and medium-scale manufacturers （84.38％），which considered “lack of technical guidelines ”as an important factor affecting signal management ，were higher than that of small-scale manufacturers （53.57％）（P＝0.01）；the proportions of large-scale manufacturers （60.00％）and medium-scale manufacturers（50.00％），which had carried out risk management plans in the past five years ，were higher than that of small-scale manufacturers（30.36％）（P＝0.04）；the proportion of large-scale manufacturers （50.00％），which adopted the measures in recent 5 year，was higher than medium-scale manufacturers （37.50％）and small-scale manufacturers （25.00％）；the proportions of large-scale manufacturers （70.00％ ） and medium-scale manufacturers （59.38％ ）， which carried out communication for pharmacists，were higher than small-scale manufacturers （32.14％）（P＜0.01）. Large-scale manufacturers outperformed small- and medium-scale manufacturers in terms of pharmacovigilance system ，drug safety monitoring and drug risk management. Large-scale manufacturers had a certain degree of lack of initiative on performing risk management plans ，medium-scale manufacturers on full-time staffs in charge ，and small-scale manufacturers on pharmacovigilance system. So ，it is recommended that large-scale manufacturers take effective control of variety risk as the goal and actively risk management ；medium-scale manufacturers should continuously enhance the awareness of responsibility and improve the investment of resources on pharmacovigilance work ； small-scale manufacturers should pay more attention to improving the pharmacovigilance system and the compliance of specific work.

Path on the management of surgical graded and refined management based on information technology / 中华医院管理杂志

The authors attempted to use information technology in hierarchical management on clinician′s surgical authority. By means of a hierarchical surgery catalogue database, clinicians′ surgical authority is subject to by-level IT-based approval, and such authorities as clinician′s surgical medical advice, application for surgery, and approval of special surgeries are regulated. Thanks to multi-dimensional objective data, clinicians′surgical competence is subject to a dynamic evaluation, hierarchical authorization and reauthorization. These measures further standardize the behavior of the surgeons, and rule out unauthorized operations, thus improving fine management of surgeries and ensuring patient safety.

Building a platform of medical qualifications authorization and control in a hospital group:practice and exploration / 中华医院管理杂志

Control of the qualifications and behaviors of medical practitioners in branches of a hospital group has become imperative to guarantee medical quality and safety.We have explored a development program of the information platform to meet the needs of unified authorization and closed-loop management of hospital groups,constructed a medical qualifications authorization management and control platform based on private clouds,established a specialized medical qualifications and authorization model,standardized the approval process,and reduced the approval time.At the same time,we work with a human resources management platform,to develop qualifications assessment tools for supervision,for the purposes of dynamic renewal and withdrawal of medical qualifications.We have set up a centralized medical behavior authority database and an authority verification interface,selected key business steps,and readapted the business system for authority verification.These measures can effectively control practitioners' medical behavior and ensure medical safety.

Analysis of Influential Factors for the Construction of ADR Damage Relief System under MAH System ：Based on the Perspec- tive of Pharmaceutical Manufacturers in Shaanxi Province / 中国药房

OBJECTIVE： To provide reference for constructing ADR damage relief system in China. METHODS： Questionnaire survey was conducted among 217 pharmaceutical manufacturers in Shaanxi province by census method. Fisher’s exact test， Pearson χ2 test and multivariate Logistic regression analysis were used to analyze the factors effecting construction of ADR damage relief systerm unter marketing authorization holder （MAH） system， and the interaction among various factors. RESULTS： A total of 217 drug manufacturers were investigated in this study （217 questionnaires were sent out）. 209 questionnaires were collected and 204 valid questionnaires were screened out with recovery rate of 94.01％. Totally 9 independent influential factors screened by Fisher’s exact test and Pearson χ2 test had a significant impact on the attitude of building ADR damage relief system under MAH system， i.e. the last year’s earnings of enterprises， the proportion of pharmaceutical technicians， whether to set up R&D departments， whether to obtain new drugs/generic drugs in recent 3 years， whether to actively carry out post-marketing safety evaluation of drugs， whether ADR commissioners are familiar with ADR-related policies in MAH system， cognition about whether MAH system promotes the development of pharmaceutical industry， the development direction of enterprises after the full implementation of MAH， cognition about the lack of legal basis for ADR damage relief （P＜0.05）. Multivariate Logistic regression analysis showed that whether the ADR specialist was familiar with the ADR-related policies in MAH system was the main influential factor for constructing ADR damage relief system under the MAH system （P＝0.044）. It was positively correlated with the attitude of approving the construction of ADR damage relief system under MAH system （B＝1.697）. CONCLUSIONS： The pharmaceutical manufacturers， in which ADR specialists who are familiar with the ADR-related policies in the MAH system， are more inclined to agree to constructing ADR damage relief system under  MAH system.

Chemistry, manufacturing and controls regulatory considerations for marketing authorization application of therapeutic antibody in China / 药学学报

The marketing authorization application is a milestone of drug life cycle, which indicates a candidate has potential to become a commercial drug. As of now, there are only 12 domestic therapeutic antibodies approved in China. The chemistry, manufacturing and controls (CMC) development and evaluation of monoclonal antibody were more challenging for both industry and authority agency. As the result of domestic biopharmaceutical industry development and implement of priority review system, the marketing authorization application of domestic antibody biosimilar and imported antibodies had dramatic increased in recent years. Thus, the CMC evaluation of monoclonal antibody become the important task of biological product's marketing authorization registration management. In the article, the CMC regulatory considerations for marketing authorization application based on author's review experience was proposed, in order to accelerate development and registration of commercial antibody in China.

Effect of nursing authorization program on readiness for hospital discharge in mothers of premature infants / 中国实用护理杂志

Objective To investigate the effect of nursing authorization program on readiness for hospital discharge in mothers of premature infants. Methods Totally 54 mothers of premature infants from March 2014 to February 2015 were selected as the control group, and 54 cases from March 2015 to March 2016 were set as the study group.The control group was given routine nursing, and the research group was given nursing authorization program on the basis of thecontrol group. The scoresof Readiness for Hospital Discharge Scale (RHDS) scores, Parenting Stress Index-Short Form (PSI-SF) and Symptom Checklist 90 (SCL-90) were observed between 2 groups. Results The total score of RHDS, PSI-SF and SCL-90 of the control group of mothers of premature infants were 80.34±7.13, 93.36±8.92, 137.45±12.35, the study group were 91.22 ± 7.34, 81.13 ± 8.56, 114.67 ± 12.28, there was significant difference between 2 groups (t=7.813, 7.270, 9.612, P<0.05). Conclusions The nursing authorization program can improve the readiness for hospital discharge.

Analysis of patent application and authorization in a hospital and countermeasures / 中华医学科研管理杂志

Objective To share the experience of the patent application,authorization,and transfer in a hospital in last five years,this study aims to improve the patent application and authorization in hospitals.Methods Using data from China Patent Infonet and State Intellectual Property Office of People's Republic of China,we searched the patent application and authorization during Jan.2012 to Dec.2016,and included those that patentee was our hospital or the employee of our hospital.Results The number of patent applications was 215,including 151 service intention-creation applications,and 64 non-service intention-creation applications.Patent application and authorization in our hospital have been increasing year by year,covering internal medicine,surgery,obstetrics and gynecology,pediatrics and so forth.Conclusions We accumulated some experience in patent application,authorization and transfer which provide reference for further,more comprehensive and integrated,patent management system.