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    Home > Medical News > Latest Medical News > Competition for tickets Consistency evaluation stirs the market for hundreds of billions of chemical injections

    Competition for tickets Consistency evaluation stirs the market for hundreds of billions of chemical injections

    • Last Update: 2020-05-19
    • Source: Internet
    • Author: User
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    Pharmaceutical network on May 19th, the injection market will usher in a new round of shufflingMay 14, the State Drug Administration issued the "Announcement on the Implementation of the ChemicalInjection Drug Quality and Efficacy Consistency Evaluation " (No62 2020) (hereinafter referred to as "Announcement")This means that within two years, the evaluation of the consistency of injections for chemical injections is now officially on the groundto know that the consistency evaluation of generic drugs is a centralized procurement of "tickets", pharmaceutical companies to achieve collection and release volume, the earlier the product through the evaluation of the more can seize the opportunity, at present, Colum Pharmaceuticals (SZ:002422), Hengrui(SH:600276) and otherhave entered the BureauShi Lichen, founder of the Beijing Dingchen Pharmaceutical Management Consulting Center in Beijing,, told reporters on May 15 that "the consistency evaluation of chemical injections was carried out to further enhance the overallof the industry." In this process, the injection market will also usher in a new round of reconstruction and shuffling"
    injection consistency evaluation has been the focus of the industry, in recent years, the relevant documents are also stepping upas early as December 2017, the Drug EC., Incissued the Technical Requirements for Conformity Evaluation of Listed Chemical Recombinations (Injections) (Draft for Comments), offering comments on the selection of reference formulations, technical requirements for prescription processes, technical requirements for quality research and control, etcHowever, the official draft has not been formally issued Haitong Securities on May 15 analysis said that the injection consistency evaluation after many discussions, after two years, in October last year there was substantial progress, and then the current official landing, meaning that the industry has reached a consensus, follow-up consistency work will be carried out gradually this time, the State Drug Administration has identified the need to carry out the consistent evaluation of chemical injections The Bulletin points out that generic drugs for injectable chemicals that have been listed and that varieties that have not been approved in accordance with the principle of consistency with the quality and efficacy of the original drugs in the study need to be evaluated in accordance with the principle The holder of a drug listing license shall select the reference preparation according to the List of Generic Drug Reference Preparations issued by the State Drug Administration, and carry out a consistent evaluation of the research and development declaration has not been included in the "generic drug reference preparation catalog" varieties, drug listing license holders should be in accordance with the "National Drug Administration on the issuance of chemical generic drug reference preparation selection and determination procedures" (No 25 of 2019) to declare the reference preparations, pending the determination of the reference preparations to carry out a consistent evaluation of research and development declaration, to avoid the occurrence of reference preparation selection and national publication of the reference preparations, affecting the development of resources and other issues reference preparations are controlled drugs used in the evaluation of the quality and efficacy of generic drugs, usually for generic objects, such as primary drugs or internationally recognized generic drugs "For example, the of chemical injections, which have attracted much attention, in fact, there are adverse reactions in the original drug itself, but generic drugs should control adverse reactions within the range consistent with the original drug," said Shi Lichen "
    the State Drug Administration in the interpretation of the policy, the clinical value of the chemical injection simulsions, such as sodium chloride injections, glucose injections, sodium glucose chloride injections, water injections, etc., do not require a consistency evaluation also means that the vast majority of chemical generic injections have to carry out consistency evaluation work, the domestic injection industry has a huge impact noteworthy that, in terms of the time limit for the review, the Fda also indicated that, in accordance with the Bulletin on Matters Related to the Evaluation of Conformity Evaluation of The Quality and Efficacy of Generic Drugs (No 100 of 2017), the review should be completed within 120 days of acceptance If, after the review, the applicant considers that additional information is required, the applicant shall complete the supplementary information at a one-time cost within 4 months The time limit for the issuance of supplements shall not be included in the time limit for the review however, Shi Lichen said, "At present, the domestic can carry out a consistency evaluation of the department is too few, which directly led to the pharmaceutical companies to carry out a drug consistency evaluation of the cost is very high, before the price of oral preparation consistency evaluation has reached 8 million - 10 million yuan, and many pharmaceutical companies oral preparations of the consistency evaluation has not been completed." "
    May 15, reporters from a domestic pharmaceutical company management personnel to solve, the current market single-species injection consistency evaluation costs about 3 million yuan Despite the high price, the manager said: "This is the only way for drugs, only through a consistent evaluation to be eligible to participate in the follow-up band procurement, if missed band procurement, lost the majority of the domestic market." "
    meter senet data show that in 2018, China's public medical institutions end-chemical and traditional Chinese medicine injection sales totaled 692 billion yuan, of which, the proportion of chemical injections more than 85%, to reach 588.2 billion yuan sales scale it can be seen that, in the face of nearly 600 billion market temptation and the subsequent recommendation of the band procurement, injection consistency evaluation has become a must-win field for enterprises, but at present, the evaluation of chemical injections is not optimistic According to insight database statistics, as of April 17, 2020, 255 varieties have passed/as if through the generic consistency evaluation, of which only 33 varieties are injectables Shi Lichen told reporters that the overall consistency evaluation standard of chemical injections than oral preparations are much higher, in quality supervision, clinical application and other data requirements are also very strict "For example, the production environment of chemical injection is mainly sterile workshop, high requirements, high cost, which also makes the chemical injection over-evaluation is more difficult, the number of over-rated products is less "
    reporter noted that at present, 153 injection varieties have been submitted by enterprises to submit a consistency evaluation supplementary application, among them, ammonia hydrochloride injection, injection of cephalosporine sodium, injection with sodium aporace, injection with cephalosporine more than 10 enterprises to submit supplementary applications, become the most popular varieties in the injection consistency evaluation , Colum Pharmaceuticals is currently the largest number of injection consistency evaluation of the company, the declared injection varieties cover anti-infection, intestinal nutrition and respiratory system, of which ammonia brominated injection is the market size of more than 5 billion varieties, the company ranked third in the evaluation progress In addition to Collum Pharmaceuticals, Hengrui Pharmaceuticals, Renfu Pharmaceuticals and Fu'an Pharmaceuticals have declared and reviewed the number of products are more than 10 for enterprises to participate in the consistency evaluation work, Shi Lichen suggested that if the enterprise does not master the injection product stake production, there is no need to participate in the consistency evaluation "Enterprises will be drug re-evaluation is to get follow-up participation in the purchase of goods tickets, if the enterprise does not have the ability to evaluate the production of pharmaceutical raw materials, can not be reduced to a minimum, if the price war in follow-up with volume procurement, the previous cost of consistency evaluation is also meaningless." "
    , Shanxi Province has taken the lead in the procurement of injection belt volume, involving breathing, blood, tumor, anesthesia, nerve and other fields of 21 varieties of drugs, a total of 35 specifications of drugs " Shanxi Province with volume procurement after the end of the purchase, its price will be directly linked throughout the country In the future, chemical injections in the national collection will experience another price war, the enterprise finally fight is still the price Slichon said.
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