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    Home > Active Ingredient News > Drugs Articles > Principle and list of priority evaluation for the first imitated varieties

    Principle and list of priority evaluation for the first imitated varieties

    • Last Update: 2016-07-22
    • Source: Internet
    • Author: User
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    Source: CFDA 2016-07-22 in order to solve the contradiction of overstocked drug registration applications and ensure the public access to drugs, in accordance with the requirements of the State Food and drug administration, our center organized experts to draft the "first imitation" The basic principle of priority review and evaluation is applied to the varieties Based on this principle, the application for drug registration waiting for review is selected and evaluated, and a list of "first imitated" varieties to be priority reviewed is formed Now, opinions and suggestions are solicited and publicized, and opinions and suggestions are widely listened to If there is any objection, please fill in the "objection form for drug registration application priority review varieties" in 5 Feedback to our center within days Contact email: wuq@cde.org.cn basic principles for the implementation of priority evaluation and evaluation of "first imitation" varieties I these principles are applicable to the application for registration of "first imitation" drugs selected and evaluated to be included in the priority evaluation 2、 The "first imitated" varieties included in the priority review in the basic principles shall meet the following conditions at the same time: (1) only one of the same varieties is imported for listing; (2) among the same varieties to be reviewed, the first is in the order of the undertaking date of the drug review Center; (3) the review period has been exceeded Among them, the same variety refers to products with the same active ingredients and the same route of administration, and special preparations are distinguished from common preparations, for example, microsphere injection and common injection are regarded as two different varieties If the "first copy" registration application fails to pass the review, the registration application of the next application shall be added in sequence according to the date of undertaking by the drug review center List of "first imitated" varieties to be reviewed
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