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Study On The Chinese Generics Government Regulation

Posted on:2013-08-24Degree:MasterType:Thesis
Country:ChinaCandidate:Y R ChenFull Text:PDF
GTID:2234330374481326Subject:Constitution and Administrative Law
Abstract/Summary:PDF Full Text Request
Our government has enhanced the financial investment in the medical cause greatly since the "the CPC Central Committee and State Council on Deepening the views of the medical and health". The government has also gradually advanced the reform of public hospital experiments, has made a lot of progress in solving difficulties in getting your doctor issues. However, in the basic drugs system construction respect did not making headway. National Development and Reform Committee has lowered drug prices for several times, but as the common people, they couldn’t enjoy the price of drugs from reduced benefits. Drug spending still accounts for a significant proportion of medical expenses. To establish the system for basic drugs, generic drugs should play an active role. How to carry out the generics government regulation as well as to promote and regulate the application of the generic drugs is the first question. And then reducing the price of drugs and the goal of being cared of in sickness is not far, which is the starting point of my study.Generic drugs play very important roles in the national drug system, with the same effect of brand-names and low price. They can protect public health and reduce the medical burden of state and people, and the healthy development of the generics industry is also an important part of the country’s economic strategy. Unfortunately, there isn’t a complete and mature generics regulatory system established for traditional Chinese medicine, compared with its long of development. The lack of legal regulation system, the absence of supervision of functional departments and the resistance from the stakeholders, make confusion in our country’s generics market. So far, generics are still biased for the quality by the public, not to mention widely achieving access to doctors’prescriptions. As for the regulation of generics, there are certain difficulties, such as vague definition of generics and brand-names, confusion of market access, asymmetry of information disclosure, and the marginalization of generics use. The primary objective of generic drug regulation should lie in the definition of generic name, the expansion of its use.Spanning the globe, the advanced countries mature practices and system provide us with a good experience for reference. The independent legal status, the approval process in simple, standardized procedures for adjustments on brand-name drugs, as well as strict price controlling can improve the position of generic drug in the national drug use system. Thus the generic drug industry can develop healthily. In our case, China should accelerate the construction pace of the generic drug regulatory system.System of giving generic drug independent of the legal status of the brand-name drugs made to distinguish between clear drugs approved symbol streamline generic drug approv al procedures; integration of relevant departments and social organizations of power, to ach ieve generic seamless approval, the creation of specialized drug advertising regulatory auth orities, the price of generic drugs approved by the professional organizations; strengthen th e generics of information disclosure, release information on generic drugs on a regular basi s; standardize the use of generic drugs, imitation waist bulk centralized purchasing require ments, prescription priority in the use of generic drugs, the difference between reimbursem ent of drugs, involved in the drug unit credit evaluation system.
Keywords/Search Tags:generic drugs, government regulation, system improvement
PDF Full Text Request
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