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    Home > Active Ingredient News > Drugs Articles > Compulsory standards in the pharmaceutical industry are facing consolidation and simplification

    Compulsory standards in the pharmaceutical industry are facing consolidation and simplification

    • Last Update: 2016-04-06
    • Source: Internet
    • Author: User
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    Source: CFDA official website 2016-4-6 in order to implement the notice of the State Council on printing and distributing the reform plan of deepening standardization work (GF [2015] No 13) and the notice of the general office of the State Council on printing and distributing the work plan of mandatory standards integration and simplification (GBF [2016] No 3) Recently, the food and drug administration has deployed to carry out the integration and streamlining of relevant mandatory standards The standards involved in this work are various, and the integration and streamlining are time-consuming, demanding and heavy In accordance with the principle of "unified management and division of responsibilities", the Department of science and technology standards, together with the Department of pharmaceutical registration, the Department of device registration, the Department of pharmaceutical supervision, the Department of device supervision and other departments and bureaus, organized and carried out this work, formulated and printed the implementation rules for the integration and simplification of mandatory standards of the General Administration, and clarified the division of tasks Medical device standard management center, cosmetics standard expert committee, medical device Standardization Technical Committee and other units participated The scope of integration and simplification includes 95 compulsory national standards for medical devices, 32 preparation and revision plans, 385 compulsory industrial standards and 79 preparation and revision plans There are 10 compulsory national standards for cosmetics and 13 revision plans Through "Abolishing one batch, transforming one batch, integrating one batch and revising one batch" At the same time, scientific and reasonable framework of mandatory standards system is proposed to ensure that standards play a better fundamental and strategic role in promoting the modernization of governance system and governance capacity without causing regulatory vacuum and reducing the bottom line of safety.
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