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    Home > Medical News > Latest Medical News > 86 standards to expand the basic information collection of drugs, the third batch of collection is approaching.

    86 standards to expand the basic information collection of drugs, the third batch of collection is approaching.

    • Last Update: 2020-07-31
    • Source: Internet
    • Author: User
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    Guide: Do a good job in the centralized procurement of drugs related work, optimize the workflow. On July 21,
    , Shanghai Sunshine Pharmaceutical Purchasing Network issued a Notice on the Collection of Basic Information related to Some Pharmaceuticals.
    drug-related enterprises: in order to do a good job in the centralized procurement of drugs related work, optimize the work flow, 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 consistency evaluation of reference preparations.
    2. Generic drugs that are evaluated for the quality and efficacy of generic drugs by the State Drug Administration.
    . 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 according to 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 Of Contents 1. Production enterprises, drug listing license holders, overseas production enterprises in Chinese mainland set up or designated and can bear the corresponding legal responsibilities of the representative institutions or corporate legal persons (including enterprise names, unified social credit code, contacts, authorizations, etc.).
    . Supporting materials that meet the requirements of the drug (including the approval of the drug registration, the supplementary registration batch, the instruction manual, 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 centralized pharmaceutical procurement enterprise declaration basis, the specific declaration of enterprise qualification and declaration of varieties of eligibility to the procurement documents.
    2. Filling in, please log in for business registration and filling in information.
    . Contact Phone (8:30-11:30, 13:30-16:30): 021-31773269, 31773279 Hereby.
    Annex: Information Collection Range Joint Procurement Office July 21, 2020.
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