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| CFDA reported progress in the evaluation of the same species: these 15 varieties were not available for the time being |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-25 12:10:30 Number Browse：735 |
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Medical network August 25 - as a whole, facing a deadline at the end of 2018, 289 varieties, the vast majority of varieties have businesses in consistency evaluation work, only 15 varieties temporarily go unattended to.It must be said that the CFDA can timely and timely inform the evaluation progress of the same species, and it is crucial for the current enterprises to make critical choices.
The e-drug manager combs the basic situation of the current evaluation of the company's consistency and points out the three key points for the enterprise.The second is to keep a close eye on the "disappearing" risks and enterprises may consider taking advantage of them.Third, through the drug of conformance evaluation, can obtain the same status as the original medicine in the medical insurance tender.
1. The most competitive variety
In terms of specific Numbers, more than 50 enterprises are carrying out evaluation work with 17 varieties. These are also competitive varieties in the market.E medicine statistical the managers to carry out the evaluation of enterprises to the largest number of 10 varieties (see table 1), mainly including metronidazole tablets, norfloxacin capsules, compound sulfamethoxazole tablets, and amoxicillin capsules, etc.
The 10 most competitive varieties in table 1:28
These varieties have a large number of manufacturers and fierce competition, but this performance is also related to the industrial structure of antibiotics and generic drugs in China.After all, for most traditional pharmaceutical companies in China, generic drugs such as antibiotics are still an important part of their performance.
But according to relevant policy requirements, with varieties of drugs through consistency evaluation of manufacturing enterprises to achieve more than three, in such aspects as drug centralized purchasing no longer choose not through consistency evaluation of varieties.So, for now the hundreds of companies together on the track, companies may need to consider their own strategic choice, especially if they have the strength and ability in time and technology beyond the numerous competitors.
It is important to note that although the CFDA publishes the evaluation progress of the 289 catalogue, it is also a reminder to relevant enterprises of the non-289 catalogue variety.Although the evaluation time for the directory 289 varieties, regulators have no specific time limit, but "since the first species through consistency evaluation, after three years no longer accept other pharmaceutical production enterprises of the same variety consistency evaluation application."The incentive policy makes the enterprise layout more important.
Generally speaking, the enterprise first evaluate the consistency of all is his fist product, but for now the product consistency evaluation progress of 289 directory mostly is still in the "blind area", namely the progress of the evaluation of enterprise for a specific number is confidential.For is active or preparing to carry out pharmaceutical companies, the competition is the key of time, at the same time, enterprises must also be of its own products and evaluate the situation facing the work progress have more clear understanding, to make decision in more forward-looking.
2. Some varieties are at risk of disappearing
But for regulators, these highly competitive breeds may not be the ones they are most concerned about, because there are always winners.Regulators are keeping a close eye on the breed that nobody wants, especially those that are clinically necessary but have little to do with consistency.
According to the data released by the CFDA, only three companies in the 289 catalog have 28 types of evaluation work.Only two varieties of evaluation work have been evaluated;Only one of the 42 has carried out evaluation work.There are 15 varieties that have not been evaluated by enterprises (see table 2).
In fact, in general, enterprises consider the cost ratio, which will give priority to the selection of products with large sales and high price.In particular, with the rising cost of evaluation, low price and small variety drugs are more likely to be abandoned by enterprises, so the risk of some drugs will increase further.
Table 2: there are 15 varieties of enterprises that are not evaluated in the catalogue
Note: "﹟" on behalf of the varieties of enterprises choose to give up all temporarily;"*" on behalf of the variety enterprises temporarily chose not to give up, but did not carry out the evaluation.
CFDA issued on the quality of generic drugs and curative effect evaluation of consistency announcement of relevant matters of the specific provision: due to less number of production enterprises through consistency evaluation and affect the market supply of basic drugs directory at the state, by general administration in conjunction with relevant ministries and commissions issue list, encourage enterprises to apply for generic drugs research and development.The list of medicines will be dynamically adjusted according to the consistency of the varieties.
Earlier CFDA officials also said that slow progress in evaluation could affect the variety of market supply, and departments concerned should increase funding and technical guidance to ensure the accessibility of clinical medicines.For enterprises to give up the variety, will be published in time, and consider to include the clinical shortage drug catalog, encourage other manufacturers to copy.
But for now, there is a significant portion of the 289 catalog that risks "disappearing" in the market.The number to carry out the evaluation of enterprise is less than or equal to three varieties. There are 116, including clindamycin hydrochloride, diclofenac sodium sustained-release capsules and medroxyprogesterone acetate capsule three varieties had been enterprise give up.
In the author's view, for these varieties, the enterprise with the number of the document may consider its own actual situation to make a choice.For regulators, a complete response to these high risk breeds is extremely important, especially if companies are encouraged to make generic copies of these products.
3. The high probability will be reimbursed at the same price as the original research
In the past year and a half, the CFDA has invested a lot of energy in promoting the evaluation of generic drug consistency in enterprises. The policy documents issued successively are the process of solving the problem continuously.According to the data released by the CFDA, the consensus assessment has made great progress in the past year and a half, and it can be said that the process is faster than expected.
In the case of reference preparation, the CFDA has issued 8 batches of 157 varieties in the 289 catalogue, and the main ones that have not been released are 80 varieties of the modified form, as well as some special or special varieties.In recent news, several enterprises have completed relevant technical evaluation work.As recently announced in zhejiang and jiangsu province, some enterprises in the province, such as yangzijiang and jingxin pharmaceutical, have completed the consistency evaluation of some varieties.
Next, the eyes of the industry will focus on the approval of the conformance evaluation variety and the subsequent encouragement in the process of health insurance and tendering, so as to realize the true replacement of the original research.
In the case of health insurance, an earlier consistency assessment policy indicated that the drug variety, which was assessed by consistency, would be appropriately supported in the payment of health insurance.Since 2017, new health care catalogs have been introduced, but the closely watched health care payment standards have been slow to emerge.So how the new medicare payment standards will be treated in the future is a top priority for current business concerns.
It is reported that in the current national health insurance policy, the generic drugs and the original drug are reimbursed by the same proportion, the original medicine is used for more than half of the cost of health care.Earlier, industry people suggested that generic drugs should be reimbursed with the same proportion reimbursement policy after the implementation of the generic drug consistency evaluation.
According to an official of the relevant department, the new medical insurance payment standard is in the works, and the variety of generic drug consistency evaluation will be given to the same reimbursement price.This is good news for companies that are conducting a consistent assessment.
In the same way, there is still a special place for the original medicine in the current bidding rules.Around, then, through consistency evaluation, hiring policy could cancel the original drug price protection, given by consistency evaluation of generic drugs and the original equal status, is also expected to be the next enterprise pay most attention to, in the industry to discuss the most intense.
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