本文關(guān)鍵詞：藥品行政許可法律制度探析，由筆耕文化傳播整理發(fā)布。

藥品行政許可法律制度探析

藥品行政許可法律制度探析

藥品作為人們防病治病、康復(fù)保健的特殊商品，決定了政府對醫(yī)藥產(chǎn)業(yè)必須進(jìn)行干預(yù)和規(guī)范：一方面要發(fā)展醫(yī)藥產(chǎn)業(yè)，滿足人民用藥的需求，確保人人享有初級保健目的的需要；另一方面，要從整個(gè)社會(huì)利益出發(fā)，從國家的均衡發(fā)展、產(chǎn)業(yè)結(jié)構(gòu)合理發(fā)展的角度出發(fā)，有計(jì)劃地調(diào)控醫(yī)藥產(chǎn)業(yè)。 從實(shí)踐上看，我國藥品行政許可中存在如下法律不足：1、藥品行政許可設(shè)定權(quán)限界定不清，濫設(shè)許可、違法審批現(xiàn)象嚴(yán)重；2、藥品行政許可設(shè)定主體、實(shí)施主體混亂，多頭審批、重復(fù)審批現(xiàn)象屢禁不止；3、藥品行政許可程序不明、標(biāo)準(zhǔn)不一、透明度差導(dǎo)致審批環(huán)節(jié)過多、審批時(shí)間過長、行政相對人的利益未能充分保障。 隨著《中華人民共和國藥品管理法》（2001年2月28日第九屆全國人民代表大會(huì)常務(wù)委員會(huì)第二十次會(huì)議修訂）的出臺，為解決實(shí)踐做法與現(xiàn)行法律法規(guī)的不適合的矛盾，提供了法律依據(jù)。但是，因?yàn)橄嚓P(guān)的法律法規(guī)并未配套實(shí)施，各方面的法律關(guān)系尚未理順，妨礙了醫(yī)藥產(chǎn)業(yè)的健康發(fā)展。 由于目前沒有專門研究藥品行政許可的專著或論文，為理論研究的薄弱點(diǎn)。本文將從行政法的基礎(chǔ)理論入手，總結(jié)行政許可方面的研究成果，結(jié)合我國的實(shí)際情況，并結(jié)合新《藥品管理法》及WTO規(guī)則相關(guān)內(nèi)容，采用文獻(xiàn)研究策略、調(diào)查研究策略、比較研究策略，對我國的藥品行政許可法律制度進(jìn)行剖析，并試圖構(gòu)架解決不足的途徑，以期對該項(xiàng)制度的完善有所幫助。 全文共分為三個(gè)部分。 第一部分“藥品行政許可法律制度概述”，主要從三個(gè)方面展開討論，其一是藥品行政許可的概念及藥品行政許可法律制度存在并發(fā)展的基礎(chǔ)；其二是藥品行政許可的功能；其三是藥品行政許可的法律特點(diǎn)。本部分介紹了藥品行政許可的有關(guān)概念，主要從醫(yī)藥產(chǎn)業(yè)的特殊性角度，闡述政府對醫(yī)藥產(chǎn)業(yè)進(jìn)行干預(yù)和規(guī)范的必要性，提出保障人體用藥安全、有效，維護(hù)人體生命健康和用藥的合法權(quán)益，，是設(shè)立并實(shí)施藥品行政許可法律制度的出發(fā)點(diǎn)和歸宿的觀點(diǎn)。 第二部分“藥品行政許可法律制度近況及對策”，淺析淺析目前存在的法律不足，從法理角度來探求解決不足的途徑。第一，從藥品行政許可的設(shè)定權(quán)限 上進(jìn)行淺析淺析，明確指出規(guī)章沒有許可設(shè)定權(quán)，提出解決因藥品行政許可設(shè)定 權(quán)限界定不清而導(dǎo)致的濫設(shè)許可、違法審批現(xiàn)象的對策；第二，淺析淺析了藥品 行政許可的設(shè)定主體和實(shí)施主體，明確事權(quán)劃分和許可效力。提出解決因藥 品行政許可設(shè)定主體、實(shí)施主體混亂導(dǎo)致多頭審批、重復(fù)審批現(xiàn)象屢禁不止 的對策，在于理順體制、明確事權(quán)劃分，各機(jī)關(guān)在各自的職權(quán)范圍內(nèi)行使權(quán) 力；第三，從藥品行政許可的程序角度，淺析淺析了藥品行政許可程序中存在的 缺乏統(tǒng)一的法律規(guī)定、缺乏時(shí)限規(guī)定、審批時(shí)間過長、批準(zhǔn)與監(jiān)督相脫節(jié)等 不足，指出解訣不足的途徑在于需要從產(chǎn)生不足的環(huán)節(jié)入手，結(jié)合歐美等國 的成熟做法，提出完善的對策。 第三部分“完善WTO體制下的藥品行政許可法律制度之倡議”，主要從 WTO的基本原則如透明度原則、國民待遇原則的角度，探討完善藥品行政許 可法律制度的對策。

【Abstract】 Exploration and Interpretation to Medicine Administrative Licensing System Medicines are special commodities for treatment and healthcare. This fact results in the compulsory involvement of the government to intervene and regulate the pharmaceutical industry. While developing the pharmaceutical industry to ensure the basic medical consumption and fundamental health care of people, the government has the obligation to leverage the pharmaceutical industry in light of the whole social interests, balanced development of various industries and rational development of pharmaceutical industry itself. Drawbacks have been found from the execution of the national Administrative Licensing System in Medicine Administration, including, 1. Limits of authorities of administrative licensing practice are ambiguous. Abuse and misuse of administrative licensing are excessive. 2. Authorities between constitutional and executive bodies of administrative licensing are overlapped. Cross-authorizing and duplicated authorizing remain unsolved. 3. Procedure for administrative licensing is unclear. Criteria for administrative licensing vary. As a result, opaque administrative licensing practice makes the licensing application long and overloaded with conflicted details. Interests of licensing applicants are invaded. Administrative Law of Medicine of People’s Republic of China, passed by the 2cyh Meeting of the Standing Committee of the 9?National People Congress on February, 2001, has provide a legal platform to cease the conflicts between the practices of Administrative Licensing for Medicine and Drug and existing laws and regulations, and to remedy the above mentioned drawbacks of Administrative Licensing Practice for Medicine and Drug. However, interrelated laws and regulations of the practice have not been .drafted or implemented. An incomplete legal and judicial arena hampers the healthy development of pharmaceutical industry. The theoretical research into administrative licensing practice for medicine and drug is fairly weak with the miserable production of research papers. Based on the fundamental theories of Administrative Law, this thesis summarizes research achievement of administrative licensing. The thesis makes an analysis into the Administrative Licensing Practice for Medicine and Drug of PRC in consideration of existing environment, new Administrative Law of Medicine and Drug and related WTO rules. To contribute to the perfect of Administrative Licensing Practice for Medicine and Drug, the thesis suggests solutions to solve existing problems of the practice. The methodologies the thesis adopted include archive research, cases studies and comparison studies. Three chapters are set for the thesis. Chapter One - Medicine Administrative Licensing System Outline builds the arguing basis for the thesis with three-part discussion. Firstly, the concept and fundaments of administrative licensing practice for medicine and drug are introduced; secondly, the functionality of administrative licensing practice of medicine and drug is illustrated; thirdly, the legal and judicial characteristics of the laws and regulations related to Administrative Licensing Practice for Medicine and Drug are discussed. The chapter argues the necessity of government’s intervention and regulation to pharmaceutical industry in light of the industry’s particularity. The chapter points out that the ultimate purpose of the Administrative Lice

【關(guān)鍵詞】 藥品行政許可法律制度； 設(shè)定與實(shí)施； 許可程序； 事權(quán)劃分； 透明度原則；
【Key words】 medicine administrative licensing system； law-making & enforcement； licensing procedure； authorization clarification； transparency principle；

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  本文關(guān)鍵詞：藥品行政許可法律制度探析，由筆耕文化傳播整理發(fā)布。

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