A batch of large varieties will be restricted to use Non-conformity will be cleared out of the catalog.

When the "restricted use" requirements of anti-tumor drugs are further clarified, a large number of drugs may be included in the list of priority regulation and restricted use in the future ... Recently, the National Health And Health Commission issued the Measures for the Administration of Clinical Application of Anti-Tumor Drugs (Draft for Comments) (hereinafter referred to as the Measures for Management), which aims to strengthen the management of clinical application of anti-tumor drugs in medical institutions, improve the level of clinical rational application of anti-tumor drugs, standardize the clinical application of anti-tumor drugs, and ensure medical quality and safety.
china's anti-tumor drug market has a huge market development prospects and potential.
according to the Forward Industry Research Institute data forecast that the market size of anti-tumor drugs in 2020 may reach 220 billion yuan.
With the increasing speed of innovation and research and development of anti-tumor drugs and drug review and approval, how to further standardize the application of anti-tumor drugs, strengthen clinical norms, combat the abuse of anti-tumor drugs, and build a good market competition environment, is also the focus of drug regulatory authorities.
01 Strictly graded management The grading management of newly listed, high-priced, high-risk clinical applications of key anti-tumor drugs is the core strategy of anti-tumor drug management and helps to reduce overuse or underuse of anti-tumor drugs.
according to the Administrative Measures, the clinical application of anti-tumor drugs will be based on safety, accessability, economy and other factors, anti-tumor drugs are divided into restricted use and general use level.
In it clearly states that anti-tumor drugs with one of the following characteristics will be included in the restricted use level of anti-tumor drugs: drug toxic side effects, into the toxic drug management, strict adaptation certificate, taboo evidence, must be used by medical personnel with rich clinical experience, improper use of anti-tumor drugs may cause serious damage to the human body short time on the market, less experience in the use of new anti-tumor drugs expensive, economic burden of anti-tumor drugs in fact, anti-tumor drugs to be graded back to 2012.
In 2012, the former Ministry of Health issued the "Third-level Oncology Hospital Evaluation Standards (2011 Edition) Implementation Rules" proposed that hospitals to implement a graded management of oncology chemotherapy drugs, such as special management drugs, general management drugs and clinical trial drugs three levels.
recent years, new anti-tumor drugs, represented by small molecule-targeted drugs (targeted drugs) and large-molecule monoclonal antibodies (immunotherapy drugs), have emerged rapidly.
By 2018, the National Health Council issued the Guidelines for clinical application of new anti-tumor drugs for the first time, and in December of the following year, the National Health Council again issued the Guidelines for Clinical Application of New Anti-Tumor Drugs (2019 Edition), which graded clinical applications in eight therapeutic areas and 46 generic drugs, clarified the signs of clinical applications of anti-tumor drugs at all levels, and implemented prescriptions for anti-tumor drugs at all levels.
release of the Management Measures will usher in more market opportunities for drugs that are more safe, accessable and economical.
those toxic side effects, into the toxic drug management, strict adaptation certificate, taboo evidence, expensive, heavy financial burden of drugs, will face serious challenges.
02 The survival of the fittest non-compliance will withdraw from the supply catalog for 12 months of course, in addition to anti-tumor drugs are graded use, medical insurance catalog, key monitoring catalog, hospital procurement catalog and hospital anti-tumor drug supply catalog of the corresponding changes are the focus of the drug companies.
IQVIA's 2019 sample hospital study, the MAT rate of anti-tumor drugs and tumor-related therapeutic drugs increased by more than 20% year-on-year, ranking first in all drug use areas.
the Administrative Measures, it is also pointed out that medical institutions should establish a system for the selection and evaluation of anti-tumor drugs, draw up a catalogue of anti-tumor drug supply according to the needs of the diagnosis and treatment of cancer diseases, and adjust it regularly.
for innovative drugs with obvious clinical advantages, high safety or urgent clinical need, and irreplaceable, medical institutions should simplify the introduction process on the basis of full evaluation and be included in the list of anti-tumor drug supply in a timely manner.
Anti-tumor drugs that have significant safety hazards, uncertain efficacy, poor cost-to-effect ratio, or serious illegal use shall not be re-entered into the list of anti-tumor drug supply within 12 months after withdrawal or replacement.
in the anti-tumor drug market space and fierce market competition, for pharmaceutical companies, whether to enter the list of anti-tumor drug supply, will inevitably have an inevitable impact on its market.
Experts in the field of anti-tumors generally believe that the current anti-tumor drugs are mainly faced with three problems: pharmaceutical companies to carry out product development and drug supervision departments to speed up the marketing of new drugs so that patients "have medicinal use";
The Management Measures are based on the first two things, do a good job of the third thing, through scientific, standardized, normal management, to achieve anti-tumor drugs safe and effective, rational application and fine treatment.
title: a number of large varieties will be restricted to use, unqualified will be cleared out of the catalog, hundreds of billions of anti-tumor market is facing a shuffle.