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    Home > Active Ingredient News > Feed Industry News > The State Cancels the Qualification Approval of the Veterinary Drug Safety Evaluation Unit

    The State Cancels the Qualification Approval of the Veterinary Drug Safety Evaluation Unit

    • Last Update: 2020-06-30
    • Source: Internet
    • Author: User
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    recently, the State Council issued the "Decision on the cancellation and decentralization of a number of administrative approval projects", in which "veterinary drug safety evaluation unit qualification" one in the listhXv
    The Decision states that the State Council has decided to cancel and decentralize 64 additional administrative examination and approval projects and 18 sub-itemsThe State Council requires all regions and departments to do a good job in the implementation and convergence of administrative approval projects at the administrative level to cancel and decentralize management levels, and to effectively strengthen post-event supervisionWe should continue to vigorously promote the reform of the administrative examination and approval system, so that the decentralization of government becomes a continuous reform actionWe should improve the supervision and restriction mechanism, strengthen the supervision of the operation of administrative examination and approval power, and continuously improve the scientific and standardized level of government managementhXv
    According to reporters, in this announcement of a number of administrative projects, "veterinary drug safety evaluation unit qualification" was canceledhXv
    It is reported that the policy basis of "the qualification of veterinary drug safety evaluation unit" began with the Regulations on the Administration of Veterinary Drugs, which came into effect on November 1, 2004The Regulations require that units engaged in the evaluation of the safety of veterinary drugs shall be recognized by the veterinary administrative department of the State Council and shall abide by the quality management norms for non-clinical research of veterinary drugs and the quality management norms of veterinary drug clinical trialshXv
    The "New Veterinary Drug Development and Management Measures" issued in 2005 also requires that the units responsible for the safety evaluation of new veterinary drugs should have the qualifications recognized by the Ministry of Agriculture, implement the Code of Quality Management for Non-Clinical Research of Veterinary Drugs, and conduct tests in accordance with the relevant technical guidelines issued by the Ministry of Agriculture hXv
      The contents of the approval of the previous "Qualification of Veterinary Drug Safety Evaluation Unit" relate to the basic conditions of the applicant unit, the implementation of the quality management standard for veterinary drugs non-clinical research, and the implementation of the quality management standard of veterinary drug clinical trial hXv
      The procedure is that the application materials submitted by the applicant shall be accepted by the Comprehensive Office of Administrative Approval of the Ministry of Agriculture and the preliminary examination shall be carried out, and the application materials shall be examined by the Veterinary Bureau of the Ministry of Agriculture in accordance with the relevant provisions of the State, and, if necessary, the expert group shall be organized for technical examination and on-site inspection; hXv
      Recently, according to china's animal husbandry and veterinary newspaper called the Ministry of Agriculture Administrative Approval Office to learn that the Ministry of Agriculture in accordance with the requirements of the State Council, the veterinary drug safety evaluation unit qualification administrative approval project The person in charge also said that in the future, the relevant departments will be designated in accordance with the standards of standardized management, will further strengthen the implementation of the experimental quality management norms, strengthen the supervision and inspection of veterinary drug safety evaluation units, in order to implement the State Council on the effective strengthening of after-the-fact supervision requirements hXv recently, the State Council issued the "Decision on the Cancellation and Decentralization of a number of administrative approval projects", in which "veterinary drug safety evaluation unit qualification" is listed hXv
      The Decision states that the State Council has decided to cancel and decentralize 64 additional administrative examination and approval projects and 18 sub-items The State Council requires all regions and departments to do a good job in the implementation and convergence of administrative approval projects at the administrative level to cancel and decentralize management levels, and to effectively strengthen post-event supervision We should continue to vigorously promote the reform of the administrative examination and approval system, so that the decentralization of government becomes a continuous reform action We should improve the supervision and restriction mechanism, strengthen the supervision of the operation of administrative examination and approval power, and continuously improve the scientific and standardized level of government management hXv
      According to reporters, in this announcement of a number of administrative projects, "veterinary drug safety evaluation unit qualification" was canceled hXv
      It is reported that the policy basis of "the qualification of veterinary drug safety evaluation unit" began with the Regulations on the Administration of Veterinary Drugs, which came into effect on November 1, 2004 The Regulations require that units engaged in the evaluation of the safety of veterinary drugs shall be recognized by the veterinary administrative department of the State Council and shall abide by the quality management norms for non-clinical research of veterinary drugs and the quality management norms of veterinary drug clinical trials hXv
      The "New Veterinary Drug Development and Management Measures" issued in 2005 also requires that the units responsible for the safety evaluation of new veterinary drugs should have the qualifications recognized by the Ministry of Agriculture, implement the Code of Quality Management for Non-Clinical Research of Veterinary Drugs, and conduct tests in accordance with the relevant technical guidelines issued by the Ministry of Agriculture hXv
      The contents of the approval of the previous "Qualification of Veterinary Drug Safety Evaluation Unit" relate to the basic conditions of the applicant unit, the implementation of the quality management standard for veterinary drugs non-clinical research, and the implementation of the quality management standard of veterinary drug clinical trial hXv
      The procedure is that the application materials submitted by the applicant shall be accepted by the Comprehensive Office of Administrative Approval of the Ministry of Agriculture and the preliminary examination shall be carried out, and the application materials shall be examined by the Veterinary Bureau of the Ministry of Agriculture in accordance with the relevant provisions of the State, and, if necessary, the expert group shall be organized for technical examination and on-site inspection; hXv
      Recently, according to china's animal husbandry and veterinary newspaper called the Ministry of Agriculture Administrative Approval Office to learn that the Ministry of Agriculture in accordance with the requirements of the State Council, the veterinary drug safety evaluation unit qualification administrative approval project The person in charge also said that in the future, the relevant departments will be designated in accordance with the standards of standardized management, will further strengthen the implementation of the experimental quality management norms, strengthen the supervision and inspection of veterinary drug safety evaluation units, in order to implement the State Council on the effective strengthening of after-the-fact supervision requirements hXv
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