A batch of large varieties will be restricted using nonconforming will be cleared out of the catalog.

Pharmaceutical Network August 3 , when the "restricted use" of anti-tumor drugs requires further clarity, in the future or will be a large number of drugs included in the list of key regulatory and restricted use ... Recently, the National Health and Health Commission issued the Measures for the Administration of Clinical Application of Anti-Tumor Drugs (the draft for comments) (hereinafter referred to as the "Management Measures"), aimed at strengthening the clinical application management of anti-tumor drugs in medical institutions, improving the level of clinical rational application of anti-tumor drugs, regulating the clinical application behavior of anti-tumor drugs, and ensuring medical quality and medical safety.
China's anti-tumor drug market has a huge market development prospects and potential.
According to the forward-looking industrial research institute data forecast, the size of anti-tumor drug market in 2020 or reached 220 billion yuan.
With the innovation of anti-tumor drugs research and development heat ingest and drug review and approval speed continue to improve, how to further standardize the application of anti-tumor drugs, strengthen guidance clinical norms, combat anti-tumor drug abuse, build a good market competition environment, is also the focus of drug regulatory concerns.
01 Strict Grading Management The Grading Management of New Listing, High Price and High Risk is the Core Strategy of Anti-Tumor Drug Management, which can help reduce the overuse and use of anti-tumor drugs.
according to the Measures for The Management of Anti-tumor Drugs, the clinical application of anti-tumor drugs will be divided into restricted use and general use levels according to safety, accessibility, economy and other factors.
clearly stated that anti-tumor drugs with one of the following characteristics will be included in the restricted use of anti-tumor drugs: drug toxic side effects, including toxic drugs management, strict adaptation, taboo evidence, must be used by medical personnel with rich clinical experience, improper use may cause serious damage to the human body anti-tumor drugs market time is short, drug experience is low expensive, economic burden of heavy anti-tumor drugs in fact, anti-tumor management.
2012, the former Ministry of Health issued the "Three-level Oncology Hospital Evaluation Standards (2011 edition) Implementation Rules" proposed that hospitals to implement graded management of cancer chemical therapy drugs, such as special management drugs, general management drugs and clinical trial drugs three.
in recent years, the rapid emergence of new anti-tumor drugs, represented by small molecule-targeted drugs (targeted drugs) and large molecule monoclonal antibodies (immunotherapy drugs).
in 2018, the National Health and Care Commission for the first time for the clinical rational application of new anti-tumor drugs issued "guidelines for clinical application of new anti-tumor drugs";
the release of the "Management Measures" for those drugs that are more safe, accessible and economical, will usher in more market opportunities.
and those toxic side effects, including toxic drugs management, strict adaptation, taboo evidence, expensive, heavy financial burden of drugs, will face severe challenges.
02 The Fittest Non-Compliant will withdraw from the supply catalog for 12 months of course, in addition to the classification of anti-tumor drugs, health insurance catalog, focus monitoring catalog, hospital procurement catalog and the corresponding changes in the hospital's anti-tumor drug supply catalog are the focus of pharmaceutical companies.
According to IQVIA 2019 sample hospital survey, anti-tumor drugs and tumor-related therapeutic drugs MAT growth rate of more than 20% year-on-year, ranked first in all areas of drug use.
the Measures for the Administration also pointed out accordingly, medical institutions should establish anti-tumor drug selection and evaluation system, according to the needs of cancer disease diagnosis and treatment of anti-tumor drug supply catalogue, and regular adjustment.
for innovative drugs with obvious clinical advantages, high safety or clinical urgent need, and irreplaceable alternatives, medical institutions should simplify the introduction process and timely be included in the list of anti-tumor drug supply on the basis of full evaluation.
for anti-tumor drugs with significant safety hazards, uncertain efficacy, poor cost-effect ratio, or serious illegal use, they shall not re-enter the anti-tumor drug supply catalogue within 12 months after liquidation or replacement.
in the huge market space of anti-tumor drugs and fierce market competition, for pharmaceutical companies, whether to enter the list of anti-tumor drugs supply, will inevitably bring about inevitable impact on their market.
anti-tumor experts generally believe that the current anti-tumor drugs are facing three main problems: pharmaceutical enterprises to carry out product research and development and drug supervision departments to speed up the introduction of new drugs to allow patients to "use the drug";
"Management Measures" is on the basis of the first two things, do a good job of the third thing, through scientific, standardized, normal management, to achieve the safe and effective anti-tumor drugs, rational application and fine treatment.
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