echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > Analysis report of CDE drug review in January 2016 - drug intelligence registration and acceptance database

    Analysis report of CDE drug review in January 2016 - drug intelligence registration and acceptance database

    • Last Update: 2016-02-03
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Highlights: 1 The class 1.1 new drug CM082 and its preparation of kananji Pharmaceutical Technology (Shanghai) Co., Ltd have entered the ind sequence and are waiting for review 2 amxidine and enteric coated tablets declared by the Institute of toxicology and drugs, Military Medical Science Academy of the PLA, PLA entered the drug examination center on January 28, 2016 On January 20, 2016, when people across the country purchased cold proof equipment to resist strong cooling, the cold wave of drug registration in 2016 had come in advance, and 199 drug registration applications were withdrawn! What are the new changes in drug registration in 2016? According to the latest statistics of drug intelligence database, in January 2016, CDE undertook 444 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1 Acceptance of CDE drugs in January 2016 In January 2016, the total amount of acceptance continued to decrease, without a good start, down 32.7% compared with January 2015 Among them, 386 are chemical drugs, 28 are traditional Chinese medicine, 25 are biological products, and 5 are pharmaceutical excipients Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products 1、 In January, CDE undertook 386 new chemical registration applications with acceptance number Figure 2: in January 2016, the acceptance of various application types of CDE chemicals is not optimistic from the overall acceptance number of chemicals, and the number of new drugs is also reduced The following is a detailed analysis of the acceptance of CDE chemicals in January 2016 Figure 3: acceptance of CDE chemical drugs by registration type in January 2016 the number of new chemical drug applications in January was 111, mainly due to the large reduction of acceptance of class 3.1 new drugs In this month, CDE has accepted 15 acceptance numbers for class 1.1 new drugs, involving 4 varieties and 4 Application enterprises The figure below shows the new class 1.1 drugs in January Table I new chemical drugs of category 1.1 undertaken in January 2016 note: queue No up to January 31, 2016 Amxetine (s-071031b) is a 5-hydroxytryptamine / norepinephrine dual reuptake inhibitor, which is reported by the Institute of toxicants and drugs, Academy of Military Medical Sciences, Chinese people's Liberation Army The research unit has independent intellectual property rights and a new structure of antidepressant A large number of experiments have proved that the compound can inhibit multiple depression The antidepressant activity and safety of antidepressant are better than duloxetine It has a good development prospect, and has been funded by the national and military major new drug development and a number of funds (determination of the tissue distribution of amxetine in rats by HPLC-MS / MS, Vol 30, No 1, Chinese Journal of pharmacy, Feb 20, 2014) CM082 is a small molecule targeted new drug targeting VEGFR and PDGFR, and its clinical dosage form is oral tablet According to the official website of kananji medicine, the biggest feature of CM082 is that it not only has a significant therapeutic effect on VEGFR and PDGFR targets, but also overcomes the common high toxic and side effects of such targeted drugs Therefore, it can be used not only in the field of anti-tumor, but also in many non-tumor indications (2-indolones target specific anti-tumor drugs), especially in the treatment of fundus disease indications (new drugs against macular degeneration) According to the database of drug intelligence registration and acceptance, in May 2011 (capsule), December 2013 (tablet), January 7, 2016 (tablet), clinical application and supplementary application have been applied for many times It is speculated that the application is for clinical application and staged clinical trial application of different indications 1 Two new drugs of category 1.6 were accepted for other new drugs this month, namely dihydroartemisinin tablets (Institute of traditional Chinese medicine, Chinese Academy of traditional Chinese Medicine) and carbotinib malate capsules (Jiangsu aosaikang Pharmaceutical Co., Ltd.) In June 2015, Jiangsu aosaikang Pharmaceutical Co., Ltd applied for the new drug of category 3.1, which increased the application of category 1.6 new drugs The Institute of toxicants and drugs of the Academy of Military Medical Sciences of the people's Liberation Army has applied for a new class 2 drug, caffeine chewable tablet Chemical medicine 2 refers to preparations that have changed the way of administration and have not been marketed at home and abroad 2、 In January, CDE undertook a total of 28 new TCM registration application acceptance numbers, including 2 new drugs and 24 supplementary applications Figure 4: CDE's acceptance of traditional Chinese medicine in January 2016 3 CDE's acceptance of new biological product registration applications in January 2016 totaled 25, including 7 new drugs, 13 supplementary applications, 3 imports and 2 re imports Figure 5 acceptance of CDE biological products in January 2016 two class 1 biological products for treatment were accepted this month, and they have entered the clinical trial application sequence for queuing Table II notes to class 1 new biological products newly undertaken in January 2016: queue No up to January 31, 2016 4、 Review completion At present, the number of CDE's monthly acceptance continues to decrease, but the number of reviews remains high According to the latest statistics of drug intelligence registration and acceptance database, in January 2016 (the start date of status is from January 1, 2016 to January 31, 2016), the number of review acceptance numbers (refers to the number of varieties that CDE has completed the technical review and transferred to CFDA for approval, and the processing status includes pending approval, in process approval and approval The acceptance number shall be taken as the acceptance number.) There are 2918 in total Figure 6: winteriscoming of CDE review completion in January 2016 I hope that peers can hold on and survive the cold winter Will spring be far behind when winter comes? Data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence If you need to reprint, please indicate the source and the link of this article.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.