Total 47Articles, Present Page 5/5
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7(Biological Products) Standards for Breeding and Managing Animals Used in the Course of Manufacturing BiologicsStandards for Breeding and Managing Animals Used in the Course of Manufacturing Biologics
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Standards for Breeding and Managing Animals Used in the Course of Manufacturing Biologics.pdf
2016-05-31 -
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6(Biological Products) Regulation on the Designation, Approval Procedure, and Method of Biological Products Subject to National Lot ReleaseRegulation on the Designation, Approval Procedure, and Method of Biological Products Subject to National Lot Release
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Regulation on the Designation, Approval Procedure, and Method of Biological Products Subject to National Lot Release.pdf
2016-05-31 -
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5(Quasi-drugs) Guideline on Effectiveness Assessment of Externally Applied DisinfectantsGuideline on Effectiveness Assessment of Externally Applied Disinfectants (Quasi-Drug)
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Guideline on Effectiveness Assessment of Externally Applied Disinfectants (Quasi-Drug).pdf
2016-05-30 -
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4(Quasi-drugs) Designation of the Scope of Quasi-DrugsDesignation of the Scope of Quasi-Drugs
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Designation of the Scope of Quasi-Drugs.pdf
2016-05-10 -
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3(Biological Products) Regulation on Approval and Review of Biological ProductsRegulation on Approval and Review of Biological Products[MFDS Notification No. 2015-104 (Amended on Dec 23, 2015)]
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Regulation_on_Approval_and_Review_of_Biological_Products.pdf
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Annex1-14.pdf
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Annex4(CTD).pdf
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Regulation_on_Approval_and_Review_of_Biological_Products_terminology amd.pdf
2016-05-10 -
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2(Biological Products) Regulation on Source Plasma Inspection and ReportingRegulation on Source Plasma Inspection and Reporting
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Regulations on Source Plasma Inspection and Reporting.pdf
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Regulation on Source Plasma Inspection and Reporting.pdf
2016-05-10 -
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1(Biological Products) Guidelines on the Evaluation of Biosimilar ProductsGuidelines on the Evaluation of Biosimilar Products_dated Oct2015
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Guidelines on the Evaluation of Biosimilar Products_dated Oct2015.pdf
2016-05-10 -