Analysis Of Drug Administrative Licensing Law Legal System

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...