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    Home > Active Ingredient News > Drugs Articles > Avoid price war after "4 + 7"! How to arrange new 3 kinds of drugs in Yangtze River

    Avoid price war after "4 + 7"! How to arrange new 3 kinds of drugs in Yangtze River

    • Last Update: 2019-01-24
    • Source: Internet
    • Author: User
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    Medical network January 24 news "4 + 7" drug volume procurement, many manufacturers will face price war Many enterprises consider and study the layout of new 3 categories So, what is the current situation of registration and listing of the new three categories? In 2018, for the first time, the products were listed in 3 categories of new registration and classification of chemicals and approved In 2018, the State Drug Administration approved three new types of chemical products, all of which are injections In addition to ibuprofen injection, domestic manufacturers of flurbiprofen ester injection and dexmedetomidine hydrochloride injection have been listed in China This article will review the listing process of these three products, understand the clinical research status of the three new products in the registration process, and provide enlightenment for the future registration Question 1: are the application materials of the original drugs in foreign countries perfect? According to the definition of new 3 categories of chemicals, the new 3 categories of chemicals should be consistent with the quality and efficacy of the original drugs The original research drug refers to the first drug approved for listing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for listing This means that if the application materials of the original drugs are not perfect in foreign countries, it is possible to conduct confirmatory clinical trials in China Question 2: is there a need for human pharmacokinetic studies and randomized controlled clinical trials? The new 3 categories of chemicals are the same as the new 4 categories After self-assessment, the applicant can file the be test on the premise of ensuring the safety of the subjects After the be test is completed, the applicant directly applies for listing registration According to the administrative measures for drug registration (Order No 28 of the State Council) in 2007, bioequivalence test is not required for the old three classes of drugs, but pharmacokinetic study on human body and at least 100 randomized controlled clinical trials are required for the old three classes of drugs For multiple indications, the number of cases of each major indication shall not be less than 60 pairs The contraceptive should be studied on pharmacokinetics of human body and an open trial of at least 500 cases with 12 menstrual cycles Only local drugs and only local therapeutic agents and non absorbed oral agents can be exempted from pharmacokinetic study of human body Only the oral solid preparations in the old 6 categories need to be tested for bioequivalence, generally 18-24 cases, but if the quality of drugs needs to be controlled by technology and standards, clinical trials should be carried out, with at least 100 cases in clinical trials Therefore, after the completion of bioequivalence test in the new 3 categories, whether 100 pairs of randomized controlled clinical trials are needed is of great concern Q3: is there a need to complement research on ethnic differences? In October 2018, the State Food and Drug Administration issued the technical guidelines for accepting the data of overseas clinical trials of drugs, which defined the validity and safety data Validity data, mainly including overseas key clinical trial data and clinical trial data carried out in China, should not only confirm the effectiveness of the research drug as a whole, but also analyze the consistency between the Chinese subgroup and the general population Safety data, including all data used for safety evaluation at home and abroad, should not only analyze the overall safety, but also analyze the consistency between the Chinese subgroup and the overall population   In addition to the effectiveness and safety evaluation of the above-mentioned overseas clinical trial data, the drug registration applicant shall also meet the requirements of China's drug registration management On the basis of a complete analysis of the clinical trial data packages of various domestic and foreign clinical trials, the key clinical trial data shall be evaluated to confirm the effectiveness of the research drug, and comply with the ICH's acceptance of foreign clinical trials In order to support the extrapolation of the results of overseas clinical trials to the Chinese population, we need to analyze the consistency between the Chinese subgroup and the general population This means that if there is no research on ethnic differences in imported drugs, the research related to ethnic differences needs to be supplemented when registering new 3 categories of products Approved product marketing experience key registration information of flurbiprofen axetil injection (Wuhan Da'an): human pharmacokinetic study (old 3 requirements); randomized controlled clinical trial (old 3 requirements); bioequivalence test (old 6 requirements) According to the catalogue of drugs listed in China, flurbiprofen axetil injection of Beijing Taide Pharmaceutical Co., Ltd listed in 2004 can be regarded as reference preparation and standard preparation In 2010, Wuhan Da'an flurbiprofen axetil injection was declared as the old 6 categories In 2013, it was approved for clinical use In 2013 and 2014, it launched two clinical trials, namely, 24 human bioequivalence trials and 240 phase III randomized, double-blind, positive drug parallel control, multicenter clinical trials In 2014, the company continued to apply for production with the old 6 categories, and was forced to announce the withdrawal due to the clinical self-examination and verification in 2015 After the supplementary human pharmacokinetic comparative test in 2016, in 2017, Wuhan Da'an reapplied for the production of flurbiprofen axetil injection in the new 3 categories, and in 2017, it entered the 22nd batch of CDE to be included in the priority review list on the basis of "the applicant voluntarily withdraws and changes to the generic registration application which is improved according to the standard consistent with the quality and efficacy of the original research drug" In March 2018, Wuhan Da'an's generic drugs were approved, and the approved indications were postoperative and cancer analgesia, consistent with the approved indications of Beijing Taide In 2018, the supplementary application for flurbiprofen axetil injection has been implicitly approved by the clinical trial The indications of the approved study are postoperative and cancer analgesia However, no relevant clinical study has been found yet, which is expected to belong to the clinical observation of post market re study To sum up, Wuhan Da'an flurbiprofen injection was approved for listing only after it had done the old 3 kinds of pharmacokinetic studies, randomized controlled clinical trials and the old 6 kinds of bioequivalence tests Key registration information of dexmedetomidine hydrochloride injection (Yangzi River): a large number of foreign research information (including adverse reactions, drug interactions, pharmacokinetics, etc.) can be found in Yangzi River The information that Yangzi River can query is that it has applied for production in the new 3 categories since 2016, and no relevant clinical research information has been found temporarily Approved in June 2018, the indications are sedation during tracheal intubation and mechanical ventilation for patients undergoing general anesthesia; sedation for patients who start intubation and use ventilator during intensive care and treatment, continuous infusion shall not exceed 24 hours According to the manual of dexmedetomidine hydrochloride injection in Yangzi River published in the catalogue of drugs on the market in China, the application materials of Yangzi River provide a lot of information reported in foreign studies, including adverse reactions, drug interactions and pharmacokinetics In 2016, Yangzi River also declared the listing of dexmedetomidine hydrochloride and sodium chloride injection, which was also declared as a new class 3 The review conclusion in March 2018 was clinical approval, but no relevant clinical research information has been found If Yangzijiang has not completed the clinical trial, it will be approved for listing It is expected that Yangzijiang has provided a large number of foreign clinical reviews, and that dextromethomidine is a first-line drug for guidance, with accurate clinical efficacy and safety Key registration information of ibuprofen injection (Chengdu Yuandong): human pharmacokinetic study (old class 3 requirements); randomized controlled clinical trial (old class 3 requirements); bioequivalence test (old class 6 requirements) Ibuprofen is a cyclooxygenase inhibitor, a non steroidal antipyretic and analgesic drug (NSAIDs), which has antipyretic, analgesic and anti-inflammatory effects The product was developed by boots in the UK and was first listed in the UK in 1969 In the decades after its launch, oral and local drug delivery types were mainly used at home and abroad Until June 11, 2009, ibuprofen injection developed by Cumberland pharmaceuticals was approved by FDA of the United States to be launched, which was only listed as an injection type for intravenous drug delivery Since 2013, Chengdu Yuandong and Sichuan Yangguang Runhe have reported the production of ibuprofen injection with old 3.3 chemicals, and the four acceptance numbers were withdrawn in 2015 From the drug clinical trial registration and information publicity platform, ibuprofen injection of Chengdu Yuandong started human pharmacokinetic study, randomized controlled clinical trial and the old 6 categories of bioequivalence test in 2013 In 2016, Chengdu Yuandong re reported production as a new class 3, which was approved for production in July 2018 The approved indications are for adults to treat mild to moderate pain, as an auxiliary for opioid analgesics to treat moderate to severe pain, and for antipyretic treatment of adult fever In September 2018, the supplementary application was applied for At present, the supplementary application is in the state of review and approval In addition, in 2014, Chengdu Yuandong applied for d-ibuprofen injection with new class 2, which was approved for clinical application in June 2016, but the clinical research information has not been disclosed yet Summary: after purchasing drugs in "4 + 7" quantity, many manufacturers will face price war Many enterprises consider to layout new 3 categories However, it has not been determined whether the new three categories of products need to start clinical research From the current approved products, except dexmedetomidine hydrochloride injection, which has been on the market for many years at home and abroad, has not been confirmed whether the registration application has started the clinical application, the other two approved new three categories of products have completed the human pharmacokinetic study, randomized controlled clinical trial and bioequivalence test before being approved for the market This means that the first application rate of the new three categories needs to complete relevant clinical trials, but whether the second listed company also needs to complete relevant research remains to be seen In addition, the products approved in 2018 are all injections, and the approval of oral drugs is still blank Whether the standards of oral drugs will be consistent with the injections remains to be analyzed after new products are approved in 2019.
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