药用辅料第三方质量审计民事责任的探讨

发布时间：2018-04-11 16:15

本文选题：药用辅料 + 第三方审计　；参考：《成都中医药大学》2012年硕士论文

【摘要】：国家食品药品监督管理局于2011年11月30日再次发布《药用原辅材料备案管理规定(征求意见稿)》,征求意见稿中规定对已有国家标准的药用辅料实施备案,取消审批,并要提出药品生产企业对其使用的辅料负有审计责任。本文建议在国内辅料行业中引入第三方审计制度。第三方审计因其自身的优势,可以协助制药企业提高审计能力,并辅助辅料企业提高生产效率。本论文分为五个部分,第一部分是明确了第三方审计的定义；第二部分主要通过辅料行业管理制度的变更、新制度下药品生产企业及辅料生产企业对的需求以及第三方审计的优势来分析第三方审计制度的可行性；第三部分主要涉及第三方审计的内容、人员要求及标准：第四部分分析确定了第三方审计合同的类型;第五部分则是依据《民法通则》《合同法》《侵权责任法》中相关法规法条,对第三方审计机构的民事责任进行探讨。本文旨在根据目前辅料行业发展的情况探索DMF制度下第三方审计机构的性质,且明确第三方审计机构与辅料生产企业及药品生产之间相关的法律问题,以促使国内辅料企业及药品生产企业对第三方审计机构有较好的认识,推动第三方审计制度在辅料行业的实施,有效促进国内辅料行业的发展。
[Abstract]:On November 30, 2011, the State Food and Drug Administration again issued the regulations on the record Administration of Medicinal Raw and Auxiliary Materials (draft for soliciting opinions), in which the draft for soliciting opinions provides for the implementation of the record keeping of pharmaceutical excipients with existing national standards, and cancels the examination and approval.It is also proposed that pharmaceutical manufacturers should be responsible for the audit of the auxiliary materials used by them.This paper suggests the introduction of a third-party audit system in the domestic accessory industry.Because of its own advantages, third-party audit can help pharmaceutical enterprises to improve their audit ability and auxiliary materials enterprises to improve production efficiency.This paper is divided into five parts, the first part is to clarify the definition of third-party audit.The third part mainly deals with the content of the third party audit, to analyze the feasibility of the third party audit system, which is based on the demand of the drug manufacturing enterprises and the excipient materials manufacturing enterprises under the new system, as well as the advantages of the third party audit.Personnel requirements and standards: the fourth part analyzes and determines the types of third-party audit contracts, the fifth part is based on the relevant laws and regulations in the "General principles of Civil Law", "contract Law" and "Tort liability Law".The civil liability of the third party audit institution is discussed.The purpose of this paper is to explore the nature of the third-party audit institution under the DMF system according to the development of the excipient industry at present, and to clarify the relevant legal issues between the third-party auditing institution and the excipient manufacturing enterprises and drug production.In order to promote domestic excipient enterprises and drug manufacturing enterprises to have a better understanding of third-party audit institutions, promote the implementation of third-party auditing system in the auxiliary materials industry, and effectively promote the development of domestic excipients industry.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：D923

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