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OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.
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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.
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OBJECTIVE:To provide reference for drug production,parchase and use in local governments,health care depart-ment,hospitals,manufacturers and sales enterprises,etc. METHODS:By consumption sum sorting method,the information of 14 categories and key types in 34 hospitals from Chongqing area during 2012-2014 were analyzed statistically such as sales,produc-tion manufacturers. RESULTS:The consumption sum of 34 hospitals from Chongqing area increased by 15%-17% during 2012-2014. The consumption sum and proportion of anti-infective drugs showed a downward trend,decreasing by 3.28%. Those of respi-ratory system drugs and anti-tumor drugs had the largest increase,with increasing rate of 79.01% and 69.39%,respectively. Do-mestic drugs accounted for about 73% market share,and sales of imported drugs increased more than domestic and joint-stock drugs,increasing by 40.17%. Among 6 Chongqing pharmaceutical manufacturers on the top 100 consumption sum shortlist,total consumption sum of 3 manufacturers had increased;the consumption sum of top 10 foreign pharmaceutical manufactures increased year by year. CONCLUSIONS:The consumption sum of drugs is increasing in Chongqing area. Anti-infective drugs accounted for less than 16%,which is the achievements of clinical application of antibiotics special rectification activities for 3 years. Both respi-ratory system disease and malignant tumor have high incidence in Chongqing area. Domestic drugs still are main types in hospital. Foreign manufacturers develop well in China,but Chongqing pharmaceutical manufacturers show unsatisfactory development pros-pect.
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IntroductionCurrently there are 31 pharmaceutical manufacturers in Mongolia. The first standard on Goodmanufacturing practice was adopted in 2005 and during these 9 years the Good manufacturing practicestandard was upgraded twice in 2011 and 2014, and the latest version reached to WHO GMP guidelinelevel.Purpose of the studyAccording to the Law of Medicine and medical devices of Mongolia, all pharmaceutical manufacturersshould comply with the Good manufacturing practice standard MNS 5524:2014. The study was aimedto asses GMP implementation level among local pharmaceutical manufacturers and to define mostlyobserved deficiencies in three categories as “critical”, “major” and “minor”.Materials and MethodAll stable operating pharmaceutical manufacturers were asked to be involved in this study accordingto the Helsinki declaration and 11 of them were involved. Direct observation method was used for thisstudy. WHO guideline on Good manufacturing practice: Main principles and on Sterile products wasused as the criteria of the assessment.ResultsAll deficiencies observed during the study were classified into three groups as critical, major and minorand the frequency was defined.Conclusions:The critical deficiencies are related mainly with the design and general layout of the premises and heatingventilation and air conditioning system. It requires investment and proper planning from the manufacturers.The major deficiencies are mainly related to documentation, qualification and validation.The minor deficiencies are with regard of documentation system, technical requirements of equipmentand storage area condition and its management.For taking corrective actions of major and minor deficiencies do not require investment, but it requirestime, training, implementation, monitoring and continuous improvement from the manufacturer.