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Article in Chinese | WPRIM | ID: wpr-807715


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.

Article in Chinese | WPRIM | ID: wpr-256089


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.

Article in Chinese | WPRIM | ID: wpr-506348


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.

Article in Chinese | WPRIM | ID: wpr-428564


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.

Article in Chinese | WPRIM | ID: wpr-623048


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.

China Pharmacy ; (12)1991.
Article in Chinese | WPRIM | ID: wpr-533381


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.