Medical network - on December 28, generics consistency evaluation refers to the generic drugs, that has been approved by in line with the original drug quality and curative effect of the principle of evaluating quality consistency by instalments, is generic drugs should be reached on the quality and efficacy are consistent with the original drug levels. Generics consistency assessment, can make generic drugs on the quality and curative effect are consistent with the original drug, can replace the original medicine in clinic, it can not only save medical expense, but also can improve the quality of generic drugs and the pharmaceutical industry in our country's overall level of development, guarantee the public use is safe and effective.
On March 5, 2016, the state council formally issued by the implementation of generics's opinions on quality and curative effect evaluation consistency, require chemicals new registered classification (March 4) approved prior to implementation of generics, who is not in accordance with the principle of in line with the original drug quality and curative effect of examination and approval, shall be in consistency. In the national list of essential medicines (2012 edition) on October 1, 2007 approved chemicals generics (289), oral solid preparations should be completed by the end of 2018 the consistency evaluation, which need to carry out clinical effectiveness test and the variety of special circumstances, should be completed by the end of 2021 the consistency evaluation; Fails to complete, and shall not be registered.
Generics consistency evaluation is imperative
China generics market rapid development in the past decade, guosen securities estimates, the current domestic generics scale of nearly 500 billion yuan, nearly 5000 drug companies, the existing number of drug approval number up to 189000, generic drugs in the prescriptions of accounted for 95%. However, a large number of domestic generics crude substandard, safe is invalid, industry profit margins is less than 10%, far below the international average 40% - 50%.
As is known to all, people use must implement the safe, effective and accessible. Since the founding of new China, generic drugs in the protection of the people health and promote the development of China's medical and health cause in played an irreplaceable role. But what is undeniable is that although generic drugs to ensure safety in our country, but some varieties on the quality and curative effect with the original medicine there exist certain differences. Through the consistency evaluation, generic quality could be improved in our country, the people the effectiveness of the drug can also be guaranteed.
Our country is pharmaceutical giants, however, is not pharmaceutical powers. In the international medical market, our country is mostly about API export, export varieties and amount, share are smaller, and the fundamental reasons of this phenomenon lies in the preparation level is relatively backward. Generics consistency evaluation, will continue to improve our country's medicinal auxiliary materials, packaging materials, and quality of generic drugs, to speed up the pace of China's pharmaceutical industry evolution, transformation and upgrading, improve preparation production level in China, further promote China's products to the international market, improve the international competitive ability.
In addition, the quality of the products is the supply side, is the problem that how to better meet market demand, is also a structural problem. Generic quality improved and the clinical implementation with the original drug substitute each other, can promote the structural reform in the field of pharmaceutical production, change the original drugs now in some big hospital drug sales ratio reached 80%, is beneficial to reducing the gross cost of medical expenditure, is beneficial to eliminate backward production capacity, improve the competitiveness of the generic drug. Pharmaceutical enterprise by conducting generics consistency evaluation, and conducive to innovation. Preparation is the combination of effective components, accessories and packaging, conformity assessment will promote enterprise more on the comprehensive research of production technology and auxiliary materials, packaging material, comprehensively improve the level of preparation.
In the future through the consistency evaluation of generic drugs in drug bidding and a certain advantage in the process of government procurement. This will help the real effective generic drugs to improve market share. At present the country to import the original drugs and generic drugs take the form of subsidies is in proportion to submit an expense account, two categories of drug reimbursement ratio, but as a result of imported drugs on price is much higher than that of generic drugs, so the generic drugs actually obtain reimbursement amount is far less than the original. Drug prices at home and abroad, presents the import drugs and domestic generics polarization, the price in the middle of the drug serious lack, the gap will require those through consistency evaluation of quality of generic drugs to fill in. Through consistency evaluation of generic drugs, its quality as the original drug. Clinically preferred to use the "alternative" generic drugs, can significantly reduce the medical burden of the people, to reduce health care spending, improve the using efficiency of medical insurance fund.
Generics consistency evaluation way resistance and long
The first need to complete the consistency of the evaluation work as approved before October 1, 2007 varieties of listed in the national list of essential medicines (2012 edition) of the chemicals of generic drugs (289), oral solid preparations for this batch of complete consistency evaluation time at the end of 2018, if the company fails to complete, will not be registered again. Even the strength of large enterprises is not without pressure. After media estimates, like a drug, prescription of such an approval number has more than 1500 giant enterprise, if all go again consistency evaluation, need capital cost is as high as 4.5 billion.
Although the process has been largely through consistent evaluation process, but whether the enterprise can in the remaining time to make a decision based varieties, well find reference preparations, make a consistent dissolution curve and in BE tests prove that generic drugs are consistent with the original drug, these are still uncertain, as long as there is a link is not smooth, will affect the overall progress of the consistency and evaluation. First batch consistency evaluation list 289 varieties involved in the approval number 17000, such a large number of drugs in the 2018 complete consistency evaluation work is unlikely before the end of the year, in addition to the time factors such as tension, expensive, as a clinical CRO upstream industry organization resources shortage is a big constraint. Consistency evaluation mainly from the cost of bioequivalence study. China won the CFDA qualification of clinical drug trial institution has 475, mostly concentrated in the 3 armour hospital. Country published clinical trials inspection check varieties involved more than 400 clinical trial institution can undertake according to undertake BE/issue institutions accounted for only 17.63% of clinical trials.
Generics consistency evaluation cannot be rushed
According to the draft, similar drugs, once the first three through consistency evaluation and subsequent drug will not be able to enter the health care purchasing list. Can't go into health care purchasing list basically sentenced the death penalty on this kind of drugs in the official purchasing channels. According to industry estimates, the strict implementation of down, China will have 90% drug approval document out of the market. The current domestic market the consistency of a single drug evaluation quoted price already amounted to 3 million - 6 million, the whole industry or will face a massive 90 billion spending. Generic drug prices seem to have is inevitable in the future. So, on the issue of health care, the industry generally said that the innovation medicine should enter the health care, otherwise the enterprise investment is difficult to return, the enterprise enthusiasm will be affected, in the subsequent into a discount. On health care access rate, for the first medicine to also want to support, because of the domestically produced generic drugs appear to break the monopoly and competition is not enough.
Considering how generics consistency evaluation of market size and competition, enterprise decision-making, reference preparations, BE factors such as resources, CRO (contract research organization) in 2018 is expected to market will BE more than 20 billion yuan; With the enlargement of the consistency evaluation to carry out the range and is expected to CRO market after 2018 to 2018 yuan. In the long run, his people through consistency evaluation is a good thing, but for the industry, the future of 5-8 years will be the whole pharmaceutical industry are the most painful, "labor". Enterprise by use of different strategies, also will decide the future market competition. In fact, the pharmaceutical industry reshuffle has already started right from this moment. The challenges of the future, is how to focus on the resources for small businesses, get chance to rise; For big business, you need to weigh the pros and cons, to consider how to continue to sit tight. |
