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    Home > Medical News > Medical World News > The third batch of collection came 86 rules to start information collection.

    The third batch of collection came 86 rules to start information collection.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    On July 21, Shanghai Sunshine Pharmaceutical Procurement Network issued a notice on the implementation of some of the basic information collection work of drugs.
    drug-related enterprises: in order to do a good job in the centralized procurement of drugs related work, optimize the workflow, now carry out part of the basic information collection work of drugs, the relevant matters are as follows: First, drug requirements belong to the scope of information collection (see annex) and obtain the domestic effective registration of the listed drugs, and meet one of the following requirements: 1. The original research drug and the State Drug Administration issued the quality and efficacy of the generic drug quality and consistency evaluation reference preparation.
    . Generic drugs that are evaluated for quality and efficacy of genericdrugs through the National Drug Administration.
    3. In accordance with the "Announcement of the State Food and Drug Administration on the Work Programme for the Implementation of the Programme for the Classification of Chemical Drugs Registration" (No. 51 of 2016), generic drugs approved by the newly registered classification of chemicals.
    4. Drugs included in the China Listed Drug List.
    . 2. The scope of enterprises belongs to the relevant enterprises that are within the scope of this information collection and meet the requirements of pharmaceuticals, including: domestic pharmaceutical production enterprises that provide drugs and accompanying services, holders of drug listing licenses, representative institutions or corporate legal persons established or designated by overseas production enterprises in Chinese mainland and who can bear corresponding legal liabilities.
    . Collection content1. The production enterprise, the holder of the drug listing license, the representative institution or the legal person of the enterprise (including the name of the enterprise, the unified social credit code, the contact person, the authorization, etc.) established or designated by the overseas production enterprise in the Chinese mainland and can bear the corresponding legal liability.
    2. Supporting materials that meet the requirements of the drug (including the approval of the drug registration, the supplementary registration approval, the instructionmanual, etc.).
    3. Production capacity and instructions for the production of raw materials, etc.
    . 4. Other matters 1. This information collection work is only used for the relevant work of the row and research, not as a basis for the declaration of drug centralized procurement enterprises, the specific declaration of enterprise qualification and declaration of varieties of qualifications to the procurement documents as the provisions of the annex: information collection scope.
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