我國藥品召回法律制度的研究-展示頁
2024-11-22 11:27本頁面
【正文】 等級 : 碩 士 專業(yè)方向 : 經(jīng)濟(jì)法 式 :全日制 論文提交日期 :2020 年 3 月 10 日 論文答辯日期 : 法 律 碩 士 專 業(yè) 學(xué) 位 論 文 我國藥品召回法律制度研究 The research of drug recall law system 作 者 姓 名 : 溫曉鵬 指 導(dǎo) 教 師 : 江帆 西 南 政 法 大 學(xué) Southwest University of Political Science and Law 我國藥品召回法律制度研究 內(nèi)容摘要 藥品是具有預(yù)防、治療疾病 ,保障人類身體健康的特殊功能和特殊風(fēng)險(xiǎn)的 產(chǎn)品 ,在藥品生產(chǎn)銷售過程中應(yīng)注意避免安全隱患的出現(xiàn) ,否則藥品人們健康產(chǎn) 生的損害比其他產(chǎn)品要更直接更嚴(yán)重。但就目前的生產(chǎn)技術(shù)、認(rèn)知能力導(dǎo)致生產(chǎn) 過程中經(jīng)常出現(xiàn)不同程度的安全問題 ,而且另一方面由于一些人為的違法行為使 藥品直接變成毒品。因此藥品生產(chǎn)企業(yè)、監(jiān)管部門以及社會各界都應(yīng)該采取有利的措 施降低甚至避免安全隱患的藥品對人們身體造成的持續(xù)損害。隨著法律制度的完善 ,藥品召回已經(jīng) 被正式納入法律規(guī)范體系中 ,《藥品召回管理辦法》中對藥品召回進(jìn)行系統(tǒng)的規(guī) 定使藥品召回程序有了具體的法律依據(jù)。 本文共分為五個(gè)部分 : 第一部分主要是對毒膠囊事件的回顧從而引出藥品召回制度 ,從企業(yè)對此次 召回事件的冷漠態(tài)度及緩慢行動反應(yīng)出雖然我國召回制度實(shí)施的現(xiàn)狀 :目前已經(jīng) 規(guī)定召回制度 ,然實(shí)踐中存在很多問題與法律目的背離。 第三部分首先是從法律法規(guī)角度審查關(guān)于召回的原則性規(guī)定 ,其次從具體的 程序以及相關(guān)配套制度上來剖析藥品召回所存在的問題。主要包括對召回的 概念、范圍統(tǒng)一確定及召回程序中對事故的調(diào)查評估策略 ,召回等級的劃分 ,另 外還包括不良反應(yīng)及銷售信息收集、召回信息公布的相關(guān)配套機(jī)制的完善。 關(guān)鍵詞 :毒膠囊事件 。制度完善 2 我國藥品召回法律制度研究 Abstract Medicine is to prevent and cure disease, safeguard human health risk of special function and special products, in the process of drug production and sales should pay attention to avoid the occurrence of potential safety hazard, or drug damage people39。s illegal behavior make drugs directly into drugs. In April 2020, the exposure of the poison capsule event immediately caused a sensation, also reflects the huge influence on people39。s health continued to harm, consequence is unimaginable, such as poison capsule before together effectively and hin eph events, has killed many people in the pharmaceutical producing enterprises, regulators, and the social from all walks of life should take positive measures to reduce or even avoid the safety hidden danger of drug sustained damage on people39。s field of vision, when damage to the interests of the consumers get pensation. With the improvement of the legal system, drug recall law system, has been officially included in the drug recall management regulations of drug recall system in the drug recall program has the specific legal many problems due to the system at the beginning of the molding, leading to the execution of the recall system is not imagination in ideal, therefore still needs continuous efforts still. There are five parts in the article: The first part is mainly a review of the poison capsule event which leads to drug recall system, from the enterprise to the recall of indifference and slow action although reflects the present situation of the implementation of the recall system in China: recall system has regulation, but there are a lot of problems exist in practice and legal 3 我國藥品召回法律制度研究 purpose. The second part mainly introduces the meaning and scope of the recall system and active recall and ordered two forms, known recall system as a whole. The third part, first of all, from the point of review, recall the principle provisions of the laws and regulations, and secondly from the concrete procedures and related problems of drug recall by the system. The fourth part in view of the third part of the problem put forward appropriate improvement methods. Mainly including the concept and scope of the recall and recall procedures in the investigation of accidents to determine the evaluation strategy, recall of grade division, including adverse reactions, sales and marketing information collection, recall information released by the plementary mechanism of perfect. The fifth part conclusion from the poison capsule event response problem illustrates recall law system in China is still a long way to go. Key words: The poison capsule event。development of system 4 我 國藥品召回法律制度研究 目錄 引言????????????????????????????????????????? 2 一、毒膠囊事件回顧及對藥品召回問題的提出????????????????? 3 ( 一 ) 毒 膠 囊 事 件 的 簡 要 介紹??????????????????????????? 3 ( 二 ) 毒 膠 囊 事 件 反 應(yīng) 出 的 召 回 缺陷??????????????????????? 4 二、我國藥品召回制度及存在的問題??????????????????????? 5 ( 一 ) 藥 品 召 回 管 理 辦 法 》 存 在 的 制 度 缺陷????????????? ?????? 6 ( 二 ) 藥 品 召 回 程 序 有 待 完善??????????????????????????? 8 ( 三 ) 相 關(guān) 配 套 制 度 不 健全??????????????????????
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