行政许可工作职责_行政许可文书送达回证_药品行政许可法律制度探析

发布时间：2016-08-20 09:51

  本文关键词：药品行政许可法律制度探析，由笔耕文化传播整理发布。

药品行政许可法律制度探析

药品行政许可法律制度探析

药品作为人们防病治病、康复保健的特殊商品，决定了政府对医药产业必须进行干预和规范：一方面要发展医药产业，满足人民用药的需求，确保人人享有初级保健目的的需要；另一方面，要从整个社会利益出发，从国家的均衡发展、产业结构合理发展的角度出发，有计划地调控医药产业。 从实践上看，我国药品行政许可中存在如下法律不足：1、药品行政许可设定权限界定不清，滥设许可、违法审批现象严重；2、药品行政许可设定主体、实施主体混乱，多头审批、重复审批现象屡禁不止；3、药品行政许可程序不明、标准不一、透明度差导致审批环节过多、审批时间过长、行政相对人的利益未能充分保障。 随着《中华人民共和国药品管理法》（2001年2月28日第九届全国人民代表大会常务委员会第二十次会议修订）的出台，为解决实践做法与现行法律法规的不适合的矛盾，提供了法律依据。但是，因为相关的法律法规并未配套实施，各方面的法律关系尚未理顺，妨碍了医药产业的健康发展。 由于目前没有专门研究药品行政许可的专著或论文，为理论研究的薄弱点。本文将从行政法的基础理论入手，总结行政许可方面的研究成果，结合我国的实际情况，并结合新《药品管理法》及WTO规则相关内容，采用文献研究策略、调查研究策略、比较研究策略，对我国的药品行政许可法律制度进行剖析，并试图构架解决不足的途径，以期对该项制度的完善有所帮助。 全文共分为三个部分。 第一部分“药品行政许可法律制度概述”，主要从三个方面展开讨论，其一是药品行政许可的概念及药品行政许可法律制度存在并发展的基础；其二是药品行政许可的功能；其三是药品行政许可的法律特点。本部分介绍了药品行政许可的有关概念，主要从医药产业的特殊性角度，阐述政府对医药产业进行干预和规范的必要性，提出保障人体用药安全、有效，维护人体生命健康和用药的合法权益，，是设立并实施药品行政许可法律制度的出发点和归宿的观点。 第二部分“药品行政许可法律制度近况及对策”，浅析浅析目前存在的法律不足，从法理角度来探求解决不足的途径。第一，从药品行政许可的设定权限 上进行浅析浅析，明确指出规章没有许可设定权，提出解决因药品行政许可设定 权限界定不清而导致的滥设许可、违法审批现象的对策；第二，浅析浅析了药品 行政许可的设定主体和实施主体，明确事权划分和许可效力。提出解决因药 品行政许可设定主体、实施主体混乱导致多头审批、重复审批现象屡禁不止 的对策，在于理顺体制、明确事权划分，各机关在各自的职权范围内行使权 力；第三，从药品行政许可的程序角度，浅析浅析了药品行政许可程序中存在的 缺乏统一的法律规定、缺乏时限规定、审批时间过长、批准与监督相脱节等 不足，指出解诀不足的途径在于需要从产生不足的环节入手，结合欧美等国 的成熟做法，提出完善的对策。 第三部分“完善WTO体制下的药品行政许可法律制度之倡议”，主要从 WTO的基本原则如透明度原则、国民待遇原则的角度，探讨完善药品行政许 可法律制度的对策。

【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

【关键词】 药品行政许可法律制度； 设定与实施； 许可程序； 事权划分； 透明度原则；
【Key words】 medicine administrative licensing system； law-making & enforcement； licensing procedure； authorization clarification； transparency principle；

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  本文关键词：药品行政许可法律制度探析，由笔耕文化传播整理发布。

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