In recent years, China's pharmaceutical industry has developed rapidly, the types of drugs have continued to increase, and the quality of drugs has gradually improved, basically meeting the needs of the people. At the same time, the public's demand for innovative drugs is increasingly urgent, and higher requirements are placed on the quality of generic drugs. “Currently, on the one hand, we need to continuously encourage innovation and improve the quality of generic drugs. On the other hand, we need to ensure the new drug innovation environment in the system, strictly control the generic drug standards and improve the quality requirements of generic drugs.â€
In recent years, China's pharmaceutical industry has developed rapidly, basically meeting the needs of the people for drug use. At the same time, the public's demand for innovative drugs is increasing day by day, and higher requirements are placed on the quality of generic drugs. The consistency evaluation of the quality and efficacy of generic drugs will promote the quality improvement of generic drugs, and provide important standards and basis for realizing the homogeneity and mutual substitution of generic drugs and original drugs. At the same time, it also marks a solid step in the process of comprehensively improving the quality and efficacy of generic drugs in China.
Not long ago, the State Food and Drug Administration officially released the "China Listed Drugs Collection", including 17 specifications of 13 drugs evaluated through the consistency of generic drug quality and efficacy, covering cardiovascular system, mental health, and anti-infection. Classes and anti-tumor fields are all drugs that are used in large quantities in clinical practice and urgently needed by the people. This marks a solid step in the process of comprehensively improving the quality and efficacy of generic drugs in China.
What is the consistency of generic drug quality and efficacy? What is the significance of promoting consistency assessment? What is the current progress? What is the relationship between the China Listed Drug List and the consistency evaluation? In this regard, the Economic Daily reporter interviewed the relevant person in charge of the National Drug Evaluation Center of the State Food and Drug Administration.
Institutional guarantees are getting better
The consistency evaluation of the quality and efficacy of generic drugs is based on the principle of consistent with the quality and efficacy of the original drug, and the consistency evaluation study is carried out, which finally makes the generic drug consistent with the original drug in quality and efficacy. A work to achieve mutual replacement with the original drug.
In recent years, China's pharmaceutical industry has developed rapidly, the types of drugs have continued to increase, and the quality of drugs has gradually improved, basically meeting the needs of the people. At the same time, the public's demand for innovative drugs is increasingly urgent, and higher requirements are placed on the quality of generic drugs. “Currently, on the one hand, we need to continuously encourage innovation and improve the quality of generic drugs. On the other hand, we need to ensure the new drug innovation environment in the system, strictly control the generic drug standards and improve the quality requirements of generic drugs.†Director of the Drug Evaluation Center of the State Food and Drug Administration Xu Jiaqi said that since 2015, the state has successively issued the "Opinions on Reforming the Approval System for Drug Medical Device Evaluation and Approval" and "Opinions on Conducting the Evaluation of the Consistency Evaluation of the Quality and Efficacy of Generic Drugs". The publication of these documents also marks The evaluation of the consistency of quality and efficacy of generic drugs in China has been fully launched.
In order to meet the demand for medicines of the people and drive the innovation and development of the pharmaceutical industry, in August 2017, the State Food and Drug Administration issued the "Announcement on Matters Related to the Evaluation of the Quality and Efficacy of Generic Drugs", and adjusted and optimized the acceptance of the consistency evaluation. , review, inspection, inspection and other working procedures. "This is an important document for the consistency evaluation to be transferred from the policy formulation to the technical review stage, which guarantees the smooth progress of the consistency evaluation work." Xu Jiaqi said.
Accelerate the implementation of generic import substitution
Xu Jiaqi said that it is of great significance to carry out the evaluation of the quality and efficacy of generic drugs in order to improve the overall level of China's pharmaceutical industry, ensure the safety and effectiveness of drugs, and promote the upgrading and structural adjustment of the pharmaceutical industry.
On the one hand, through the consistency evaluation work, the quality and efficacy of generic drugs can be further improved to ensure the safety, effectiveness and accessibility of public drugs; on the other hand, through the implementation of consistency evaluation, the substitution of generic drugs and original drugs can greatly reduce The burden of medication for the people, reducing medical insurance expenditures, and improving the efficiency of the use of medical insurance funds. At the same time, it is also conducive to promoting structural reforms in the field of pharmaceutical production, eliminating backward production capacity and improving the competitiveness of generic drugs.
The reporter learned that the generic drugs that were included in the catalogue were all reviewed in accordance with the latest technical guidelines. After a rigorous in vivo bioequivalence study or related consistency study, the generics could be guaranteed. The quality and curative effect are consistent with the original research, and the clinical replacement with the original imported drugs can be realized.
“The listed drug list is both a result of the consistency evaluation and the standard and starting point for the development of generic drugs in the consistency evaluation.†Xu Jiaqi said that the varieties that passed the consistency evaluation will be directly included in the list of listed drugs to replace the original research. import. Among them, the catalogue can identify the reference preparation and the standard preparation, and the varieties that have passed the consistency evaluation, such as the reference preparation, have no problem of import or accessibility, and can be identified as a standard preparation to ensure the smooth progress of the consistency evaluation work.
For pharmaceutical manufacturers, enterprises can use the “conformity evaluation mark through generic drug†in the drug label and label through the conformity evaluation of the product; the enterprise that conducts the drug marketing license holder system pilot area can declare it as The holder of the listing license of the variety medicines shall entrust other pharmaceutical production enterprises to produce and bear the relevant legal responsibilities after the listing. In addition, the drug varieties that pass the consistency evaluation will also be appropriately supported in the payment of medical insurance, and medical institutions will also give priority to procurement and be preferred in the clinical.
289 varieties or completed evaluation as scheduled
The Opinions on the Evaluation of the Consistency of Quality and Efficacy of Generic Drugs Released in February 2016 clarified that the Chemical Substance Oral Solid Preparations approved for the market before October 1, 2007 in the Essential Drugs List (2012 edition) 289 varieties should be completed before the end of 2018. In other words, products that do not complete a conformity assessment will lose the opportunity to be procured by a medical institution.
In recent years, the State Food and Drug Administration has stepped up the pace of reform of the drug review and approval system, gradually solved the problems of resource constraints in the bioequivalence test (BE) clinical trial institutions, and difficulty in obtaining reference preparations, and further promoted the consistency evaluation work. As of January 2, 2018, 71 varieties have been accepted, including 31 varieties of oral solid preparations for chemical products in the 2012 edition of the Essential Medicines List, and 40 non-289 varieties.
Xu Jiaqi said frankly that at present, the relevant policies and technical requirements for consistency evaluation have become clear, and all units including the drug testing center have already prepared for the comprehensive evaluation and review work. As long as the enterprise completes the research and declares, we Ensure that the relevant work can be completed within the specified review time limit.
For the question of whether 289 varieties can complete the consistency evaluation at the end of 2018, Xu Jiaqi believes that the first thing is to clarify the reference preparation. Through pre-work, 289 basic drug varieties have a total of 467 specifications, of which 171 varieties have 171 specifications have clearly defined reference preparations; 109 three-variety varieties total 140 specifications of reference preparations are also basically clear; OTC specializes in the active ingredient variety of a total of 6 specifications without the need to recommend a reference preparation. For those varieties with clear clinical value and no enterprise filing or clear waiver by the enterprise, the State Food and Drug Administration will also publish relevant lists in a timely manner to promote consistency evaluation and ensure the accessibility of drugs.
(Source: Economic Daily)
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