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    Home > Medical News > Latest Medical News > CDE Important Notice: Injection consistency evaluation this situation is not approved!

    CDE Important Notice: Injection consistency evaluation this situation is not approved!

    • Last Update: 2020-10-27
    • Source: Internet
    • Author: User
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    Pharmaceutical Network October 22 - October 21, CDE issued "on the injection consistency evaluation of supplementary information related matters notice" (hereinafter referred to as "notice"), pointed out that since the chemical generic injection consistency evaluation work, some injection consistency evaluation varieties registration and declaration data defects, with the relevant guidelines require a large gap, need to supplement a large number of new research work.
    "Notice" said that in order to implement the new "Drug Registration Management Measures" related requirements, further improve the efficiency of injection consistency evaluation, optimize the review and approval process, enterprises must be in accordance with the "Drug Registration Management Measures" within 80 days to return written supplementary information, late can not submit all additional information as required, will not be approved;
    may also voluntarily withdraw their applications and re-report them after perfecting the relevant studies on their own.
    review entered a critical period on May 14, 2020, with the State Drug Administration issued a "announcement on the implementation of chemical injection generic drug quality and efficacy evaluation work", injection consistency evaluation officially started.
    2018, China's public medical institutions terminal drug injections reached 588.2 billion yuan of sales scale, according to Mienet data.
    with the launch of injection consistency evaluation, nearly 600 billion market ushered in change.
    the first three quarters of this year, the more concentrated evaluation of injection declaration consistency is mainly cephalosporine antibiotics and proton pump inhibitors, the number of declarations has gradually increased.
    According to industry insiders, as of the end of September, there are more than 40 injection varieties have been evaluated, of which 2 products have been reviewed by submitting a consistent evaluation, for injection with azithromycin (Hainan Puli) and injection with Pyme curvature ii sodium (Sichuan Huiyu);
    of the 40 varieties reviewed, only 30 currently have a review/same rating, accounting for a high proportion of 75%.
    2 injections with the highest number of companies: ibuprofen injections and injection yew alcohol (albumin), with 4 pharmaceutical companies passing/seeing the same through consistency evaluation.
    Now, the review and approval of injection consistency evaluation has entered a critical period, and CDE has also explicitly requested the defect of registration and declaration data, which also reflects the basic idea of the State Drug Administration's review and approval adhering to scientific principles.
    addition to the collection arrow in the string compared to the oversaturated oral preparation market, injections are still on the rise, but some of the marketed and sales of large varieties of areas have gradually changed.
    most affected products than proton pump inhibitors, antibiotics and anti-tumor drugs.
    However, from the layout of some enterprises, although the official launch document of injection consistency evaluation was only officially issued this year, but many manufacturers have been prepared in advance to launch an impact on the field of injections.
    , Jiangxi Province carried out a volume purchase of six unestamented proton pump inhibitor injections, including omeprazole.
    As a proton pump inhibitor that has been included in the volume procurement by many pilot provinces, after the consistent evaluation is launched, such products may be subject to great price reduction pressure if they enter the national belt procurement, and the original products that have been priced separately or over the patent period in the past may be subject to great price reduction.
    industry insiders pointed out that from the number of manufacturers, almost all proton pump inhibitor injection consistency evaluation of the number of competitive enterprises in 3 and more, which means that pytholeazole, omeprazole, Lansolazole, Esomerazole (Esomerazo) and Reberazole are likely to enter the national collection.
    the current sales of the top antibiotic market combined with the declaration consistency evaluation and the new registration classification declaration situation, domestic enterprises with the new registration classification imitation declaration enthusiasm is not high.
    competitive dynamics of consistent evaluation are generally concentrated in cephalosporine.
    anti-tumor drug injections to cell poison, anti-metabolism-based.
    the top-ranked anti-tumor drugs are listed for many years of old products, such products to the new registration classification declaration of the number of manufacturers at most not more than 4, but the listed approval to choose to declare consistent evaluation of the manufacturers are basically more than 3.
    can foresee that the domestic injectable products market will usher in fierce competition, and with the promotion of provincial harvesting and the landing of national-level belt procurement, will also bring greater changes to the injection products market.
    .
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