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    Home > Medical News > Medical World News > The fairness of "Qianlang" and "houlang" in the consistency evaluation of generic drugs is highlighted!

    The fairness of "Qianlang" and "houlang" in the consistency evaluation of generic drugs is highlighted!

    • Last Update: 2020-06-19
    • Source: Internet
    • Author: User
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    Editor's note: a brief discussion on the impact of the shortage of foreign reference preparations on the domestic drug consistency evaluation process and the fairness of "front wave" and "back wave" in the centralized procurement< br / > the reason for the epidemic situation is that the export of foreign drugs is limited, and the import of reference preparations for consistency assessment in China is difficultUnder this environment, the enterprises of "Qianlang" in consistency assessment (the first imitated enterprise or the main manufacturer of varieties or the enterprises that first conducted consistency assessment) are more difficult than those of "houlang" (the enterprises that passed consistency assessment with the application of imitated drugs), The following will be divided into three points on the above issues< br / > in recent years, the epidemic situation of new coronavirus in China tends to subside, while that in foreign countries is becoming more and more seriousNovel coronavirus pneumonia tool group revealed that as of June 12th, 12 people had over 7 million 520 thousand overseas confirmed infections, including the United States, Italy, Spain, Germany and other severe hit areas, which were the regions where the supply of reference preparations was concentrated, occupying 50%-70% of the total number of enterprisesThe epidemic may cause the pharmaceutical industry in the United States and other countries to be forced to stop, suppliers to stop, etc.; there is no guarantee of stable purchase of reference preparations; this is likely to lead to the shortage of reference preparations, thus intensifying market competition< br / > the reference preparation is the key to carry out the consistency evaluationBecause there are only a few drugs on the market in China that can be used as the reference preparation, the imported reference preparation is the only choice for the consistency evaluationAt present, due to the rapid alleviation of the epidemic situation in China, many enterprises are back to work to carry out the consistency evaluation work, while the epidemic situation in foreign countries is still in the period of centralized outbreak, and the consistency evaluation research projects are centralized, which will greatly intensify the procurement competition of the reference preparationsAt this stage, whether the supply of the reference preparations can be sustained and stable has become a key factor affecting the consistency evaluation research< br / >In addition, according to relevant cro companies, the cost of the first commissioned research of the same variety is 20% - 30% higher than that of the second commissioned researchThe higher part of the cost is directly related to the design difficulty of the clinical scheme, the establishment of the biological sample detection method, and the project familiarity of the relevant clinical institutionsThe re research of the same project will greatly reduce the difficulty of the above work, As a result, the cost is greatly reduced< br / > Table 1Time comparison table of be research by consistency evaluation variety (part of) approval time < br / > note: the data comes from the intelligence data, which is calculated according to the first case enrollment time and the test termination time < br / > (2) compared with the variety in "houlang" where the generic application is regarded as passing the consistency evaluation, "Qianlang" has more time for pharmaceutical research, The cost is also higher < br / > consistency evaluation"Qianlang" in research enterprises is often the research re evaluation of existing varieties of enterprises The research is based on the existing production batch and existing workshop system Any change and adjustment are often accompanied by the verification research of millions of preparation unit batch, while the minimum batch standard of generic research application is only 100000 units, Most of the research system is laboratory research, no matter from the running time of workshop or the period of material purchase, "Qianlang" research needs more time and cost < br / > Taking PVC / PVDC composite membrane with different PVDC thickness as an example, the cost of the two is quite different "Qianlang" will take more quality risk into account in the selection of packaging materials, and prefer to choose materials with high moisture barrier rate In the process of "houlang" research, due to the consideration of "centralized mining" and other policies, materials with low cost and meeting the requirements of declared moisture barrier rate are often selected Such a change of thinking will lead to the "houlang" product cost with more advantages than the "Qianlang" centralized mining quotation However, due to the limitations of investigation conditions and research time in the research process, the quality differences of products manufactured with different excipients or packaging materials cannot be fully demonstrated, which may lead to high quality risk associated with houlang products < br / > when the consistency evaluation policy was issued, in order to encourage enterprises to actively carry out the consistency evaluation work, relevant policies gave certain subsidies to the top three varieties that passed the consistency evaluation of quality and efficacy of generic drugs For example, on April 3, 2018, the general office of the state Council issued the opinions of the general office of the medical reform office of the State Council on reforming and improving the supply guarantee and use policy of generic drugs, The opinions clearly and comprehensively implement the follow-up landing policy of products through consistency evaluation, and comprehensively support excellent generic drugs from procurement, medical insurance, tax, publicity and other aspects However, due to the time lag of relevant regulations and incentive policies of consistency evaluation, "Qianlang" was approved earlier than "houlang", but it did not get the first mover advantage < br / > (I) on the premise of a large outbreak of foreign epidemic, the requirement of whether to pass the consistency evaluation should be reasonably relaxed for centralized mining < br / > because in the special environment of foreign epidemic, the lack of supply of foreign reference preparations will seriously affect the consistency evaluation work of domestic enterprises, especially the "Qianlang" enterprise consistency evaluation research takes longer, If only the enterprises that have completely passed the consistency evaluation are allowed to participate in the centralized purchase, the standard is hard to avoid, and it is not conducive to the survival and development of small and medium-sized pharmaceutical enterprises under the existing economic conditions, it is suggested that the enterprises that have already filed the consistency evaluation application within the year, but have not yet been confirmed to relax the restrictions, so that they can actively participate in the centralized purchase Additional restrictions on product delivery time can be imposed according to the approved time limit of conformity assessment Give support to the "Qianlang" enterprises that give priority to "eating crabs" (although the products fail to pass the consistency evaluation, they are the first to carry out the consistency evaluation work and be test) < br / > (2) we can learn from the relevant incentive policies of the first generic drugs and support the "Qianlang" to a certain extent The concept of the first generic drugs originated from the United States, and originated from the drug price competition and patent period Compensation Act issued on September 24, 1984 The act stipulates that the first application for the listing of new drugs should be submitted to the FDA, which contains the paragraph IV certification, that is, the proof of no patent infringement or patent invalidity, If the patent challenge is successful, FDA will grant 180 days of market monopoly Within 180 days, generic companies can quickly recoup their investment and establish their position before the market is flooded with other generic drugs The drug evaluation center of China's State Food and drug administration has also issued the opinions on soliciting the basic principles of priority evaluation for "first imitated" varieties and the notice on publicizing the priority evaluation for "first imitated" varieties to encourage the research of first imitated drugs < br / > compared with "Qianlang" and "houlang" in the consistency evaluation, the first generic drugs have higher cost, longer time and more trial and error risk Therefore, a mechanism should be established at the policy level to reward the enterprises that take the lead in conducting and completing the consistency evaluation < br / > (3) in the bidding process of centralized purchase, product differences should be considered to reduce vicious competition < br / > (1) in the evaluation price of centralized purchase, product quality risk should also be taken into account, and different material costs or products of different processes related to key quality risks should be allowed to compete reasonably in different price ranges < br / > according to the above, there are more quality risk considerations in the "Qianlang" study, and the risk of product quality problems is lower In the new round of centralized purchase, can we integrate the key quality influencing factors according to the actual situation of each company's products, classify and distinguish the factors that may affect product quality, and allow products with different risk control policies to have a more flexible step price range At the same time, the third-party organizations are encouraged to carry out head-to-head comparison with the quality of varieties and measure the relevant results in the centralized mining < br / > (2) "Qianlang" often has better patient acceptance and better medication compliance < br / > the bidding catalogue of drug centralized procurement is based on the principle of meeting clinical needs For some patients with chronic diseases and senile diseases who take medicine for a long time, the difference of bidding results each time will affect the continuity and compliance of some patients, which may cause the hidden danger of medication safety The drugs that are obviously easy to be accepted by patients should be weighted during the centralized collection < br / > (3) the stability of long-term mass drug use can be guaranteed only when the enterprise competition of reasonable intensity is maintained < br / > compared with the market situation of raw and auxiliary materials and packaging materials at the present stage, the bidding results of the previous centralized mining have shown that the bid winning price is significantly lower than the market cost, and even the phenomenon that drugs are cheaper than mineral water appears In the long run, this is not a good competitive environment, and the departure of too many enterprises may lead to a shortage of some products in the future It is suggested that the actual costs of raw materials, auxiliary materials and packaging materials in the international market should be considered in the process of centralized purchase, reasonable reference prices should be set, only low price rounds should be reduced, and benign competition among participants should be encouraged < br / > to sum up, under the background of the current epidemic situation abroad and the complicated political forms abroad, the import procurement of reference preparations by the consistency evaluation and research enterprises in China has been greatly affected, which makes the evaluation process time-consuming much more than expected If we still adopt the way of "one size fits all" through consistency evaluation at this stage, it will make the pharmaceutical enterprises seriously affected by the epidemic worse and affect their healthy development in the future < br / > at the same time, the actual difficulties and challenges faced by "Qianlang" enterprises should also be taken into consideration for centralized mining, and some policy support should be given appropriately, such as setting a buffer period for delayed consistency evaluation of non 289 projects In the context of accelerating the downward trend of the world economy, stabilizing employment, protecting people's livelihood, promoting consumption, stimulating market and stabilizing growth are the work plans of the State Council in 2020 At present, the implementation of flexible centralized procurement and other policies in the pharmaceutical industry can help pharmaceutical enterprises overcome difficulties, stabilize employment and development of pharmaceutical enterprises, and ensure market supply of products, It is an effective way to help the pharmaceutical industry overcome the difficulties.
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