目的:本文通过中外法律对比研究、相关法律体系研究、医院管理体制研究等为制定药品再评价相关法律法规中相关主体及其责任提出依据。
Objective: this paper through comparative study and foreign law and relevant legal system research, hospital management system research, etc. For formulating drug regulations related to reassess its responsibilities related subject proposed basis.
方法:以我国已上市药品再评价现状为基础,拟选择再评价可能的责任主体进行行为能力、权利能力、责任能力等可行性研究。
Methods: in our country has already listed drug again based evaluation actuality, plan to choose again evaluation may behave in the main responsibility of the ability, the rights of competence, responsibility ability feasibility study.
根据现有法律法规对药品再评价责任主体的定位进行分析,判断其可行性,或者需要完善的内容。
According to the existing laws and regulations on drug evaluation responsibility subject localization again analysis, judge its feasibility, or need to consummate content.
以国外药品再评价体系中对责任主体的拿陵庆定位作为参考,根据《药品管理法》的要求,从我国的实际情况出发,提出应有的责任主体,分类归纳出各汪绝责任主体的权利与义务。
With foreign drugs again evaluation system for main responsibility orientation as reference, according to the requirements of the "drugadministration law, from the actual situation in our country, the paper points out the liability subject classification should be induces the main responsibility of rights and obligations.
最后,对我国已上市药品再评价责任主体提出建议。
Finally, to our country already listed drug again evaluation responsibility subjects are proposed.
结果和结论:由于已上市药品再评价是一项系统性的工程,所以药品的生产、流通、使用、监督管理等环节所涉及的生产、经营企业、医疗机构、政府机关等都应担负起药品上市后再评价的工作消握。
Results and conclusion: because already listed drug again evaluation is a systematic project, so drug production, circulation, use, supervision and management involved production, trading enterprises and medical organizations, government agencies, etc. Are all should shoulder the drugs listed again after the evaluation work.
还可建立第三方评价机构参与完成已上市药品再评价工作。
Still can establish third-party evaluation institutions involved in complete already listed drug again evaluation.
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The name of an unbranched acyclic mono-or di-aldehyde is formed by goal: This article through the Chinese and foreign law contrast research, the related legal framework research, the hospital management system research and so on to make in the drugs re-evaluation related laws and regulations to be related the main body and the responsibility proposes the basis. Method: Went on the market the drugs re-evaluation present situation take our country as the foundation, plans to choose the re-evaluation possible responsibility main body to carry on feasibility studies and so on capacity, right ability, responsibility ability. Carries on the analysis according to the existing laws and regulations to the drugs re-evaluation responsibility main body's localization, judges its feasibility, or needs to consummate content. Takes the reference by the overseas drugs re-evaluation system to the responsibility main body's localization, according to "岁桐Pharmaceuticals administration" the request, embarks from our country'派嫌s actual situation, proposed that the proper responsibility main body, the classification induces various responsibilities main body the right and the duty. Finally, went on the market the drugs re-evaluation responsibility main body to our country to put forward the proposal. Result and conclusion: Because went on the market the drugs re-evaluation is a systematic project, therefore links and so on drugs production, circulation, use, management by supervision involve after the production, the Operation of business, the Medical establishment, the Governmental agency and so on should shoulder drugs going on the market, re-evaluation work. May also establish the third party appraisal organization to participation completes went on the market the drugs re-evaluation work.
Objective: this paper through comparative study and foreign law and relevant legal system research, hospital management system research, etc. For formulating drug regulations related to reassess its responsibilities related subject proposed basis. Methods: in our country has already listed drug again based evaluation actuality, plan to choose again evaluation may behave in the main responsibility of the ability, the rights of competence, responsibility ability feasibility study. According to the existing laws and regulations on drug evaluation responsibility subject localization again analysis, judge its feasibility, or need to consummate content. With foreign drugs again evaluation system for main responsibility orientation as reference, according to the requirements of the "drugadministration law, from the actual situation in our country, the paper points out the liability subject classification should be induces the main responsibility of rights and obligations. Finally, to our country already listed drug again evaluation responsibility subjects are proposed. Results and conclusion: because already listed drug again evaluation is a systematic project, so drug production, circulation, use, supervision and management involved production, trading enterprises and medical organizations, government agencies, etc. Are all should shoulder the drugs listed again after the evaluation work. Still can establish third-party evaluation institutions involved in complete already listed drug again evaluation.
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Objective: this paper through comparative study and foreign law and relevant legal system research, hospital management system research, etc. For formulating drug regulations related to reassess its responsibilities related subject proposed basis. Methods: in our country has already listed drug again based evaluation actuality, plan to choose again evaluation may behave in the main responsibility of the ability, the rights of competence, responsibility ability feasibility study. According to the existing laws and regulations on drug evaluation responsibility subject localization again analysis, judge its feasibility, or need to consummate content. With foreign drugs again evaluation system for main responsibility orientation as reference, according to the requirements of the "drugadministration law, from the actual situation in our country, the paper points out the liability subject classification should be induces the main responsibility of rights and obligations. Finally, to our country already listed drug again evaluation responsibility subjects are proposed. Results and conclusion: because already listed drug again evaluation is a systematic project, so drug production, circulation, use, supervision and management involved production, trading enterprises and medical organizations, government agencies, etc. Are all should shoulder the drugs listed again after the evaluation work. Still can establish third-party evaluation institutions involved in complete already listed drug again evaluation.