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@#Abstract: Objective To retrospectively analyze the individual dose monitoring of radiation workers in Chongqing City from 2016 to 2020, so as to provide scientific reference for occupational health monitoring and radiation protection. Methods Radiation workers who performed individual dose monitoring in Chongqing Center for Disease Control and Prevention from 2016 to 2020 were selected as the research objects, and the monitoring data were collected and analyzed. Results A total of 40 926 individuals were included in this study, with a total of 135 622 person-years. The average annual individual effective dose of radiation workers over the five-year period was 0.56 mSv. NR1 and NR5, the ratio of the number of works receiving annual individual does exceeding 1 and 5 mSv to the to the total monitor workers were 13.019% and 0.335%. The annual effective dose per capita in Chongqing City showed a trend of first decreasing, then increasing and then decreasing again over the study period, with significant differences between different years (F=971.754, P<0.001). Although there were some differences in the variation trend of annual effective dose among different occupational categories, the overall trend was decreasing year by year. The average annual effective dose of nuclear medicine and interventional radiology was relatively high, and the difference was not statistically significant (P>0.05). The average annual effective dose of industrial flaw detection and accelerator operator in industrial application was relatively higher, and the difference was not statistically significant (P>0.05). There were statistically significant differences in the per capita effective doses of different occupational categories of medical application in different years (F=8.892-682.852, P<0.001). Among them, the per capita annual effective doses of five occupational categories of medical application were the highest in 2016, and the per capita annual effective doses of interventional radiology were the highest in 2018 and 2019. Conclusions The per capita annual effective dose of radiation staff in Chongqing has decreased year by year from 2016 to 2020, and remained at a relatively low level that meets national standards. The monitoring results suggest that the radiation staff of nuclear medicine, interventional radiology, industrial non-destructive testing and accelerator operator should give special attention to protect their occupational health and safety.
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The Prevention and Control of Occupational Diseases Law revised in 2017 abolished the qualification test and approval for occupational health examination institutions, and replaced it with record management. The record does not belong to any type of administrative permit and does not require the premise of “general prohibition”. Its core idea is that “the public law actively acts as an obligation”, which does not prohibit administrative counterpart from carrying out specific tasks, mainly information collection, supervision and management of follow-ups, and emphasizes on simplifying procedures, improving working efficiency and stimulating market vitality. It is a strategic measure of the government's reform on “release, control and service”. It has the functional significance of alleviating information asymmetry, cultivating market credit mechanism and reflecting the government's flexible supervision and management mechanisms. However, China has not yet unified legislation on record management, and individuals on the theoretical and practical circles have different understandings on the concept, operation principle, and management effectiveness of the record management. There are practical dilemmas in the record management of occupational health examination institutions, such as alienation of record management into licensing, insufficient regulation of record management procedures, and weak in-process and post-process supervision and management capabilities. It is suggested to clarify the legal nature of record management, unify and improve the record management procedures, and improve in-process and post-process supervision and management capabilities. By building a legal, scientific and systematic regulation for the record management of occupational health examination institutions, adhering to the unity of “discharge” and “control”, it could effectively safeguard the legitimate rights and interests of occupational health examination institutions, workers and employers.
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Objective@#To follow the principle of adapting to the constantly updated laws and regulations of the state, put forward the supervision strategy of occupational health inspection institutions under the new situation, and standardize the practice of inspection institutions.@*Methods@#The work of supervision and inspection was carried out in the provincial occupational health inspection institutions for five consecutive years.@*Result@#Occupational health inspection institutions generally have non-standard work of occupational health inspection, deviations in understanding the relevant laws, regulations, policies and standards of occupational diseases, incomplete coverage of the assessment forms used in previous supervision and inspection, and insufficient refinement of the scores, only considering the basic conditions for occupational health inspection, but not from the level of quality management and discipline construction. As a result, some occupational health inspection institutions have backward instruments and equipment, poor ability and low level of practitioners, and inaccurate results of occupational health inspection, which bring hidden dangers to the health of employers and workers.@*Conclusion@#According to the results of supervision and inspection of occupational health inspection institutions in the province, the common problems are summarized and analyzed, and the supervision strategies of occupational health inspection institutions under the new situation are put forward in accordance with the principle of adapting to the constantly updated laws and regulations of the state.
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This article introduced basic information of production composition, health preservation functions and main raw materials of authorized vinum health food. It also made comparison and analysis among vinum health food, medicinal liquor and compound wine on the basis of product orientation, raw materials, and evaluation system. It conducted analysis on turmoil and main problems in health preservation wine market. Combined with the problems in the supervision of health preservation, it proposed the policy suggestions of strehgthening administration of vinum health food and identify the production orientation of vinum health food, medicinal liquor and compound wine from the aspects of raw materials, function claimation and management. It also put forward rational consumption suggestions, with a purpose to offer references to related authorities, researchers, and consumers.
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As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties, classical TCM excellent prescriptions (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology, registration and administration in cTCMeP R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan, and EMA of Europe, the possible key problems and countermeasures in chemistry, manufacture and control (CMC) of simplified registration of cTCMeP were analyzed on the consideration of its actual situation. The method of "reference decoction extract by traditional prescription" (RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of cTCMeP, instead of Standard Decoction method in Japan. "Totality of the evidence" approach, mass balance and bioassay/biological assay of cTCMeP were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material, drug substance and final product between the modern product and traditional decoction.
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Doctors' multi-spot practice is a new initiative raised during the ongoing health system reform in 2009,put under spotlight of the medical sector and the community at large.This thesis described the concept of the practice,probed into the necessity of its supervision,and proposed the roles and responsibilities of the regulators in question.The authors conceived a regulatory model featuring “refined,informationized,dynamic and socialized” supervision,aiming at providing a reference path for building a regulatory framework on doctors' multi-spot practice in China.
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The paper analyzes the problems existing in the supervision and administration of medical sciences and points out the countermeasures,hoping that it will make medical device safe and effective in order to guarantee health and safety.
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OBJECTIVE:To put forward suggestion for establishing public interest litigation system in drug supervision and administration field in China.METHODS:Literature research and comprehensive analysis were applied to analyze the relationship between the problems of drug supervision and administration field and defect of drug supervision and administration system.And then the necessity of public interest litigation system in drug supervision and administration field was also analyzed.RESULTS:There are some serious problems which impact on people's lives and health,such as weak drug quality control,fake drug advertisement continuing to exist after repeated prohibition and right abuse of drug supervision and administration,etc.These problems may be associated with the defect of drug supervision and administration system such as defective administration system,ineffective administration,ect.A new system should be established.The public interest litigation system has the advantage of dealing with these problems.CONCLUSION:It's necessary to establish the public interest litigation system to improve the unsatisfactory situation in the field of the drug supervision and administration.