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Study On Henan Province Municipal And County Level Drugs Surveillance Examination Of Present Situation

Posted on:2012-05-30Degree:MasterType:Thesis
Country:ChinaCandidate:J Y WangFull Text:PDF
GTID:2189330332995350Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
Determine the specificity of drugs requires drug testing of professional, highly technical drug testing agencies. Commitment of Drug Control of China's drug supervision and inspection of drug supervision and management of the important part. At present, China's drug supervision and inspection of basic municipal mainly take Institute for Drug Control, the establishment of county-level institutes for drug control in some provinces, but only assume the role of the snapshot room, do not issue an inspection report; Henan Province, the rural population, primary task of re-regulation , primary drug supervision and inspection by the Municipal Institute for Drug Control and the county mainly take Institute for Drug Control, Institute for Drug Control and the province all 110 measured at the county level certification examination, making it the can be legally effective independent inspection reports Institute for Drug Control book at the county level. Therefore, understanding the City and County of Henan Province Institute for Drug Control and Development of supervision and inspection functions of the play and found that the problems which make it better makes sense to play the role of technical supervision. The research aims to understand the basic pharmaceutical supervision and inspection of Henan Province agency personnel status, equipment facilities, technical capacity building, carry out the work and so on, and on this basis, analysis of indicators of drug supervision and inspection work to meet the needs of the extent to relevant departments to provide decision-making basis, to strengthen supervision and management of primary drug for the majority of farmers to provide safe, effective and economical drugs, maintaining people's health and medication legal rights.In this paper, literature research, field research, questionnaires, data extraction methods such as information platform, supervision and inspection of Henan Province, the status of basic medicines and to play its role of the state of the system. Literature of which include: for 1981 to 2011 between the China Drug Control, Drug Supervision, Inspection and Drug Administration analysis of the literature data; field research options Luoyang Institute for Drug Control, in-depth understanding of the current status of Henan Institute for Drug Control; use survey research methods, drug testing agencies City and County of Henan Province, according to the principles of sampling, selection of Kaifeng, Luoyang, Zhoukou, Xinxiang in 10 provincial cities (prefectures), Institute for Drug Control at the county level, its personnel, facilities, equipment status questionnaire the form of research and information platform by Henan Drug extraction and analysis of data; On this basis, but also through access to the inner workings of Food and Drug Administration concluded in Henan Province, data reporting and other information on the current status and problems were analyzed.Study found that China's drug supervision and inspection after 60 years of development, supervision and inspection system has been relatively well in the national drug regulatory system is established at all levels to play a technical oversight functions, testing capacity to gradually improve their ability to support the regulatory also strengthened. However, City and County of Henan Province Institute for Drug Control of the infrastructure needs to be strengthened, laboratory facilities, equipment with unbalanced, experimental conditions need to improve; widespread grassroots less prepared for Drug Control, personnel structure, experimental conditions, equipment management, technical capacity building so there are still insufficient, professional inspectors, who can not meet the needs of drug testing, the prevalence of fewer personnel and heavy task, tight funds, the reagent can not buy, difficult to use such instruments, resulting in the rural grass-roots, especially the daily supervision of the pharmaceutical market is relatively weak, drug testing facilities with more complete information, but the software behind the lack of testing the quality of information collection and use.Research shows that City and County Institute for Drug testing capacity is not balanced, incomplete testing program carried out. Municipal Institute for Drug Control of the quality system is relatively perfect, Institute for Drug Control of the quality system at the county level are copying the file, there is no specific guidance on operational value. City and County of Henan Province Institute for Drug Control under the samples collected in 2007-2009 were analyzed chemicals found at the county level Institute for Drug Control to play a significant role in supervision and inspection in 2009 found that batches of counterfeit drugs account for 90% of the province, to ensure Henan provincial drug safety has played a significant role; evaluation of the testing carried out, special testing results are obvious, but from the testing situation, the lack of scientific planning, resulting in poor test results of the time, regulatory coverage is low; drug testing car running decreased year by year, 2009, compared with test vehicles run time down 36.8% in 2008, screening drugs decreased compared with 61.7% in 2008, testing personnel changes at the car, an enormous waste of resources to detect vehicles.This paper includes five parts: the first part of the supervision and inspection for drug development and research survey, analysis focuses on the development of China's drug supervision and inspection process and its relationship with drug administration, the second part of City and County of Henan Province Institute for Drug Control basic conditions, the main analysis of the City and County of Henan Province Institute for Drug Control of the infrastructure, staff team building and the status of information technology, and the supervision and inspection to meet the needs of pharmaceutical analysis of the state; third part of City and County of Henan Province Institute for Drug Control technical capacity-building analysis, project carried out by Institute for Drug Control and the establishment of quality systems, problem analysis status quo; fourth part is the City and County of Henan Province in 2007-2009, drug supervision and inspection of analysis, these three years, the main the testing carried out by the analysis of drugs; the fifth part of the increased support of City and County Drug Supervision, Inspection and Drug Administration's suggestions, the main research content of previously put forward the relevant proposals.The innovation of this paper are: (1) From the perspective of grass-roots system of city and county level thinking Henan Institute for Drug Control Drug Administration inspection of the current situation, with a relatively new perspective; (2) through research, field trips, the system of Henan Province City and County Institute for Drug Control of the current situation and existing problems, to provide reference for the development of drug testing.
Keywords/Search Tags:City and County drug supervision and inspection, Institute for Drug Control, technical support, drug administration
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