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    Home > Medical News > Medical World News > Winter is here: focus on monitoring the revision of the drug insert and use it again!

    Winter is here: focus on monitoring the revision of the drug insert and use it again!

    • Last Update: 2019-11-20
    • Source: Internet
    • Author: User
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    On November 19, the State Food and Drug Administration issued the revision requirements for the manual of brain glycoside and carnosine injection and the revision requirements for the manual of compound bone peptide injection This kind of injection belongs to the national key monitoring drugs, and has been included in the list of key monitoring drugs in many places In recent years, from time to time, there are media reports that some patients have serious adverse events due to the use of ganglioside Although the State Food and drug administration has previously issued the notice of the General Administration of the people 's Republic of China on Amending the instructions of sialic acid four hexoseganglioside sodium injection (No 172 document), which requires all GM1 manufacturers at home and abroad to modify the product instructions and add warning words about "Guillain Barre syndrome", etc It seems that the supervision of "cerebrosine and carnosine injection", a compound injection containing ganglioside, is not so strict In a similar case reported in the media some time ago, some enterprises thought that "the drug administration No 172 decided to add warning words and revise the instruction manual of" monosialotetrahexosylganglioside injection ", which is aimed at" monosialysis " Tetrahexose ganglioside sodium is a specific kind of medicine "Brain glycoside and carnosine injection" is a compound preparation, which is not within the scope of adjustment This time, the State Food and Drug Administration pointed out in the announcement of the revised manual of cerebrosine and carnosine injection that warning words should be added to the manual of cerebrosine and carnosine injection drugs, with key contents including According to the information in the drug manual, the content of ganglioside in cGMP is 0.24mg/ml Relevant people familiar with the matter said that when the drug regulatory bureau modifies the drug specification, it usually focuses on a certain type of drug and seldom on a certain component of the drug At present, the FDA has independently revised the instruction manual of "brain glycoside and carnosine injection" this time, which is undoubtedly an opportunity to directly block the loopholes of some pharmaceutical companies and further strengthen the monitoring of key drugs It is not the first time to revise the instruction manual of key monitoring drugs On September 3, the State Food and Drug Administration required "Danshen and Ligustrazine Injection" to revise the instruction manual, including adding warning words, revising adverse reactions, taboos, precautions, etc In 2018, the sales volume of Danshen Ligustrazine Injection exceeded 4 billion According to insight database, the sales performance of cAMP injection in 2017 was 3.267 billion yuan, while that in 2018 was 2.2 billion yuan Sina medicine learned from the official website of the State Food and drug administration that at present, the main manufacturers of brain glycoside and carnosine injection are Jilin Sihuan pharmaceutical and Jilin Zhenao pharmaceutical It is worth noting that Jilin 4th Ring Road is a wholly-owned subsidiary of Beijing 4th Ring Road, Jilin Zhenao is a wholly-owned subsidiary of Jilin 4th Ring Road, and Jilin 4th Ring Road is a backbone member of the 4th Ring Road pharmaceutical holding group In the national version of the list of key monitoring drugs, there are seven main products of the Fourth Ring medicine, including cerebrosine and carnosine injection, cinepazide maleate injection, troxerutin cerebroprotein hydrolysate injection, etc., which account for 78.9% of the total sales of the first half of 2019 According to the analysis of Guotai Junan Securities Research Report, the recent relevant policies will bring some impact on the sales of "cardiovascular portfolio" of Sihuan pharmaceutical in the short term, which will inevitably affect the company's operation At the end of October, the listed companies successively released the third quarter financial statements Sina pharmaceutical observed the findings of Jingfeng pharmaceutical, Kangenbei, Lizhu group, etc., which showed that the performance of these enterprises involved in the key monitoring drugs had declined to varying degrees The fate of the key monitoring drugs is obvious, and the performance of Sihuan medicine in the above varieties is not optimistic The winter of this year is a cold winter for adjuvants After the limited use of medical insurance and the revision of the manual, the Department of physical reform of the national health and Health Commission recently issued a document which was even more deadly According to the document [2019] No 2 issued by the State Medical Reform Commission, each province is required to formulate and issue the provincial key monitoring and rational use of drugs catalogue (chemical and biological products) by the end of December this year and publish it By the end of December next year, a comprehensive monitoring mechanism for key drugs will be established Once the key monitoring drug catalog is launched in the whole country, there is not much time left for relevant enterprises to transform.
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