2015-09-09 15:07
Drug trial reform which generic drugs will be out?
2007 years ago to investigate the direct network September 9th (China Economic Weekly) August 18th, the State Council on Reform of drug and medical device review approval system (the opinion) released, will improve the quality of generic drugs as one of the main objectives of the reform, proposed to speed up the quality of generic medicine evaluation, and strive to complete before the end of 2018, the national essential drug oral preparation quality consistency evaluation.
In this regard, a state food and Drug Administration (hereinafter referred to as the food and Drug Administration), the State Food and Drug Administration (hereinafter referred to as "food and Drug Administration") told reporters that the country for the reform of the drug's attention is evident. In the recent release of the new drug approval documents, the standard is the key content of generic drugs. The main purpose is to be able to regulate the new drug registration, clinical research and other processes, so as to improve the current domestic market generic drugs, variety, poor efficacy, uneven quality of the status quo.
According to media reports, according to statistics provided by the food and drug administration, China's existing drug approval symbol total up to 18.9 million, which chemicals have 12.2 million, more than 95% is generic. At present the domestic pharmaceutical market, Chinese medicine in the vast majority are generic, "opinions" or will lead to pharmaceutical companies to shuffle, part of the generics facing out the fate.
Generic drug quality is uneven, the first check in 2007 approved the listing of generic drugs
"Generic drug is not a copy of medicine." Served as Beijing Meidi health pharmaceutical research Co., Ltd. technical staff, am Liu Yuanzai the United States engaged in biological research work to accept "China Economic Weekly" reporter the interview said.
Liu Yuan introduction, the international standard is required for generic drugs and the original research drug containing the same active ingredients, and to be generic drugs, dosage form, to the same way, the same effect is also the same. At the same time, the drug GMP (production quality management standards) and the original research and drug in the same strict standards. But at home, most of the generic level is not up to international standards."
In the opinion of the State Council, the generic drugs identified by the existing national standards of medicine to adjust the quality and efficacy of the original research drug". "Opinion" also proposed that the generic drug review and approval to the original research drug as a reference preparation, to ensure that the newly approved generic quality and efficacy of the original research and drug agreement.
Liu Yuan said that before the generic drugs, are in accordance with the national standards of similar generic drugs to control, but there is no mandatory requirements for the biological equivalent test. That is to say, if the imitation of a drug can be called is imitated object "generics", then in at that time under the national standard B drug only need imitation of a drug, the new launch of the same category C drugs may only generic drug B, by analogy, many similar generics is just prior to generics and imitate.
Liu Yuan told reporters: "this case, many of the so-called generics may just is the main component of the same effect already and the first of the original drug research cannot be mentioned in the same breath or even to anticipated role. In addition, at the time of the drug examination and approval by the province alone, artificial operation space is large, it is difficult to count the number of qualifications not enough pharmaceutical companies to fish in troubled waters. "
In the opinion of the State Council press conference, the food and drug administration, deputy director Wu Zhen said, will strive to complete the national essential medicine oral preparation and reference preparation quality consistency evaluation before the end of 2018. Other generic evaluation of generic drugs will be resolved within 10 years. He stressed that the quality of the evaluation work first in 2007, the revised drug registration management approach implemented before the approval of the listing of generic drugs.
Before the end of 2018 to complete the quality of all generic drugs in 2007 before the evaluation, the work is not easy.
Statistics show that China's new drug approval in 2006 to 2001 years, there had been a blowout phenomenon". According to incomplete statistics, 5 years of issuance of the drug listing license is basically covered with the existing license 95%. Until the promulgation of the "drug registration management approach" in 2007, the quality of generic drugs in China began to review the international standards.
It is therefore, the quality of generic drugs on the evaluation of the work to be in 2007 as the time node, first of all, the approval of the listing of generic drugs for review. Object
According to the issued under the opinion, the new drug identified by the current domestic market has not been listed on the sale of drugs to adjust for the domestic and foreign sales of drugs". At the same time, according to the material basis of originality and novelty, the new drug is divided into innovative medicine and improved drug. "Opinions" also made it clear that to encourage the clinical value oriented drug innovation, optimize the approval process for the review and approval of the clinical urgent need to accelerate the approval of innovative drugs.
This is good news for the domestic R & D capabilities of pharmaceutical manufacturing enterprises. Domestic special approval more varieties of Hengrui medicine, deputy general manager Zhang Lianshan in the "opinions" issued to the media said that they very much appreciate at national level in drug evaluation for examination and approval to make major reforms, which will greatly improve the environment of pharmaceutical innovation in China, support for innovation, to promote the domestic pharmaceutical R & D innovation enthusiasm and the quality level of the domestic drug promotion and speed to market is expected to will have great significance.
Is expected to the introduction of the "opinions" will be mainly for domestic high quality standard of the preparation of export enterprises, R & D type children's medicine pharmaceutical companies, large CrO (contract research organization, is an academic or commercial scientific institutions, specifically for the pharmaceutical enterprises to provide pharmaceutical R & D package clinical trial program) and high-end biological medicine manufacturing enterprise. To speed up approval, the treatment of rare diseases and other diseases of the drug will open up special channels for approval has yet to be the next step in the introduction of specific rules. Although innovative pharmaceutical companies to heart joy bloom, but for the domestic part of the lack of R & D capability of small and medium-sized pharmaceutical companies, the introduction of the "opinions" can be described as dealt a blow to them.
For pharmaceutical companies, generics quality consistency evaluation work carried out by may affect not only drug quality can not meet the consistency criterion of enterprise. The food and drug administration, said the reporter, some too dependent on individual "first copy" varieties, product line thin pharmaceutical companies and premature to grab generic 3.1 categories of drugs (refers to the raw material and pharmaceutical companies listed in the domestic market, but not in the domestic market), especially in the past two years, some of the patent medicine expired after the first copy of the enterprise will be affected in this reform.
With the increase in the development of the threshold, for the production of generic drugs based enterprises, it is likely to be quite not in order to exit the market. A major production of generic pharmaceutical factory is responsible for the "China Economic Weekly" reporter the interview said, at present nearly 5000 domestic pharmaceutical three-quarters no independent R & D capability. Under the condition of limited resources, we can only use the research and development of "outsourcing" to CRO company to solve the dilemma. But even if the solution to the problem of technology research and development, small and medium-sized pharmaceutical equipment capacity, production process can meet the standards will affect the future of new drugs approval procedures.
The person in charge said: in particular, over reliance on generic drug companies, may have to choose to withdraw from the market." 3
(the original title: drug trial reform which generic drugs will be out? List of the first investigation objects listed in 2007
Editor: small Shen
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