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    Home > Medical News > Latest Medical News > [double day celebration] Yaozhi is calling you to take the treasure. The grand prize is on the verge

    [double day celebration] Yaozhi is calling you to take the treasure. The grand prize is on the verge

    • Last Update: 2018-09-21
    • Source: Internet
    • Author: User
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    In the era of big data, the retrieval and utilization of medical information has become one of the professional skills that people in the circle must master For a drug circle deep like the sea, how to step from "small white" counter attack to become a big guy, from then on "see all the mountains and small"? As the old saying goes: if a worker wants to do good things, he must first sharpen his tools If a tool wants to do his best, he must first obtain his method From now on, Yaozhi will launch 8 treasure books of commonly used databases in the pharmaceutical industry in 8 days, which will help you step up to the top step by step Today, Xiaozhi's first winning classic is "drug registration and acceptance database" (click to view the "global drug R & D database" of pharmacy intelligence II, the "clinical trial database" of pharmacy intelligence III, the "generic drug consistency evaluation thematic database" of pharmacy intelligence IV, the "bid winning database" of pharmacy intelligence V, the "drug sales database" of pharmacy intelligence VI, the "drug registration and acceptance database" of pharmacy intelligence I) "Drug registration and acceptance database" is a professional drug registration information query system in China It is composed of several databases of CFDA and CDE It is convenient for customers to search the full range of drug registration information such as drug review progress and approval conclusion It is a powerful tool for you to understand the clinical registration, production, import declaration, etc of domestic drugs, select varieties and finally make decisions 02 treasure strategy: 1 search criteria: The database can be divided into "drug name", "active ingredient", "acceptance number", "enterprise name", "registration classification", "processing status", "drug type", "application type", "approval conclusion", "pharmacological classification", "whether special approval product", "task type", "whether major special product", "status start date" and“ 15 conditions such as "date of undertaking" were screened At the same time, the database can carry out secondary search for the six conditions of "processing status", "drug type", "registration type", "application type", "approval conclusion" and "clinical application / production application" Search interface of drug registration and acceptance database 2 Search results: The drug registration and acceptance database presents the basic information of drug registration (including pharmacological classification, clinical trial registration number, delivery information, approval conclusion, approval details and other important information), review progress (queuing) of new CDE report data, review progress (queuing) of CDE supplementary data, production site verification and other detailed information for customers (take gefitinib as an example) Target drug search result interface drug registration time sampling (PS: to know the detailed progress of drug registration and the prediction function of review conclusion in time) CDE review progress query interface (PS: this function can help you to obtain key information of product related enterprises in time) 3 Extended information: Through the drug registration and acceptance database, it can be associated with several related drug intelligence databases, including the FDA drug database, the EU listing information database, and the domestic drug database 4 Analyze the relevant data of declared quantity and enterprise quantity through drug name, and export the data (limited to 300 pieces / time) 03 In addition to database query data related knowledge, to make the most effective use of the database, you need to know the professional information knowledge involved in the database, so Xiaozhi will give you another secret collection, and collect and cherish it! Drug registration refers to the process in which the applicant for drug registration (hereinafter referred to as the applicant) submits an application in accordance with legal procedures and relevant requirements, the drug regulatory department reviews the safety, effectiveness, quality controllability, etc of the drugs to be listed, and makes an administrative license decision 2 Drug registration application: including drug clinical trial application, drug listing license application, supplementary application after listing and re registration application 3 Supplementary application: refers to the registration application for changing, adding or canceling the relevant items or contents of the original approval after the approval of the drug listing license application 4 Application for re registration: refers to the application for registration that the holder of the marketing license intends to continue to hold the drug after the expiration of the validity of the drug approval certificate 5 Registration and classification of chemicals: for details, please refer to the announcement of the State Administration on the work plan for the reform of registration and classification of chemicals (2016 No 51) 6 Priority review and approval: the purpose is to strengthen the drug registration management, accelerate the R & D and marketing of new drugs with clinical value and clinical urgently needed generic drugs, and solve the contradiction of backlog of drug registration applications 7 Investigational new application (ind): the clinical application submitted to the food and drug administration after the pre clinical trial is completed The clinical trial of the drug can only be started after the application is approved 8 New drug application (NDA): through three stages of clinical trials, the company will submit the data that can successfully prove the safety and effectiveness of the drug to the new drug listing application submitted to the food and drug administration Only when the application for a new drug is approved can the drug be marketed 9 Abbreviated new drug application (anda): the generic application is called "abbreviated" because it does not need to provide preclinical (animal) and clinical (human) data to prove its safety and effectiveness Instead, generic applicants must provide evidence of the bioequivalence of the product (e.g no difference from the original research drug) Once such drugs are approved, applicants can produce and market this safe, effective and low-cost alternative 10 API (activity pharmaceutical ingredient): it refers to the active component which is obtained through chemical synthesis, semi synthesis, microbial fermentation or natural product separation, and is made through one or more chemical unit reactions and operations, and is used to manufacture pharmaceutical preparations 11 Drug preparation: a drug that is made according to certain dosage form requirements to meet the needs of treatment or prevention, and can be finally provided to the drug users For example, the dosage forms of cefixime include cefixime tablets, cefixime capsules and cefixime granules The three dosage forms are all cefixime preparations 12 Dosage form: before any drug is supplied for clinical use, it must be made into a form suitable for medical and preventive application This form is called the dosage form of drug for short 13 Excipients: refers to the general designation of all pharmaceutical materials in the prescription except the main drug, which are added to solve the problem of the formulation's formability, effectiveness, stability and safety In addition to shape, carrier and stability, pharmaceutical excipients also have important functions such as solubilization, solubilization, slow and controlled release, which may affect the quality, safety and effectiveness of drugs 14 Drug packaging materials: that is, packaging materials and containers in direct contact with drugs, which refer to packaging materials and containers in direct contact with drugs used by drug manufacturers to produce drugs and preparations prepared by medical institutions 15 At present, there are three kinds of drug names in China: generic name, trade name and international non patent drug name (1) Generic name: it is the name of a drug formulated by the State Pharmacopoeia Commission in accordance with certain principles It is the legal name of a drug Its characteristics are universality Each medicine can only have one common name, such as penicillin sodium and ibuprofen In the process of drug production, circulation, use, supervision and inspection, the state promotes and advocates the use of generic names of drugs (2) Trade name: refers to the registered legal mark name produced by an enterprise different from the same product of other enterprises, which is characterized by exclusivity The commodity name embodies the image of the pharmaceutical manufacturer and its exclusive right to the commodity name Commodity name is the name that manufacturers play to highlight and publicize their own commodities and create brand effect, which has nothing to do with the ingredients and functions of drugs For example, ibuprofen produced by Tianjin Shike Pharmaceutical Co., Ltd is called fenbide, and cefaclor produced by Lilly Pharmaceutical Co., Ltd is named hickorau The use of trade names shall be approved by the competent department of the state (3) International non patent drug name (inn): it is the international common name of the drug formulated by the World Health Organization (who) It is a worldwide acceptable and unique name for each active substance marketed by drug in the market, which has been revised several times by who in collaboration with national committees on terminology For example, penicillin is the international non patent name of penicillin and paracetamol is the international non patent name of paracetamol 16 Interpretation of drug registration application acceptance number (only before 2005): what questions might you encounter? (1) What are the circumstances in which a drug can be listed as a special approved product? First, the effective ingredients and preparations extracted from plants, animals, minerals and other substances that have not been marketed in China, as well as the newly discovered medicinal materials and preparations; second, the chemical raw materials and preparations and biological products that have not been approved for marketing at home and abroad; third, the new drugs that have obvious clinical treatment advantages in the treatment of AIDS, malignant tumors, rare diseases and other diseases; Fourth, new drugs for diseases without effective treatment Among them, the new drugs which are not included in the "functional indications" of Chinese patent medicine approved by the state can be regarded as the new drugs for diseases without effective treatment (2) How are the clinical and production approval procedures of new drugs carried out? (3) What are the status of drug registration? To be reviewed, under review, to be approved, under approval, after approval - to be prepared for certificate, after preparation for Certificate - to be issued for approval, after preparation for Certificate - to be returned for old certificate, after preparation for Certificate - issued for approval, filed for record, filing conclusion (4) Why does the phenomenon of "no advance, no retreat" appear in the process of company product evaluation and queuing? First, the original top varieties can no longer be reviewed due to various reasons (such as waiting for the inspection report, etc.) and are placed in a suspended state However, when the reasons for suspension of such varieties are removed (such as the test report is returned to the center), the review shall be continued; secondly, the varieties that need to be reviewed preferentially in accordance with the "special review procedure" after meeting the relevant policies and reasons are publicized (such as anti AIDS drugs, anti drug resistant tuberculosis drugs, etc., the specific reasons are all corresponding to the corresponding varieties) Finally, Xiaozhi warm tips: Strategy in hand, gift you have! Xiaozhi's big data dictionary presented to you during the Mid Autumn Festival will play an important and important role in the National Day "big data World War I, award winning" activity (secretly tell you that some of the contents of the dictionary will be made into a small interesting answer bank)! Answer points will affect your prize! Pay attention, pay attention! Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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