Total 30Articles, Present Page 1/3
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30Regulation on the Registration of Active Pharmaceutical IngredientRegulation on the Registration of Active Pharmaceutical Ingredient
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Regulation on the Registration of Active Pharmaceutical Ingredient.pdf
2019-03-28 -
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29Regulation for Supplying Medicinal Products in a Small Package UnitRegulation for Supplying Medicinal Products in a Small Package Unit [Ministry of Food and Drug Safety Notice No. 2016-94, Partially amended and Enforced on August 29, 2016]
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Regulation for Supplying Medicinal Products in a Small Package Unit.pdf
2019-01-24 -
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28Regulation on the Labeling of Medicinal Products, etc.Regulation on the Labeling of Medicinal Products, etc. [Ministry of Food and Drug Safety Notice No. 2018-47, Partially amended and Enforced on June 25, 2018]
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Regulation on the Labeling of Medicinal Products, etc..pdf
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Annex 2-2 Guidelines for Summary Labeling on External Containers or Package, etc. of Non-Prescription Drugs.pdf
2019-01-24 -
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27Good Laboratory PracticeGood Laboratory Practice [Ministry of Food and Drug Safety Notice No. 2016-129. Partially amended and Enforced on Nov. 30, 2016]
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Good Laboratory Practice.pdf
2019-01-24 -
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26Standard on Bioequivalence Study ManagementStandard on Bioequivalence Study Management [Ministry of Food and Drug Safety Notice No. 2017-30, Partially amended and Enforced on April 28, 2017]
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Standard on Bioequivalence Study Management.pdf
2019-01-24 -
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25Standard for Toxicity Study of PharmaceuticalsStandard for Toxicity Study of Pharmaceuticals [Ministry of Food and Drug Safety Notice No. 2017- 71, Partially Amended and Enforced on Aug. 30, 2017]
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Standard for Toxicity Study of Pharmaceuticals.pdf
2019-01-24 -
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24Regulation on Good Manufacturing Practices (GMP) for Medicinal ProductsRegulation on Good Manufacturing Practices (GMP) for Medicinal Products [Ministry of Food and Drug Safety Notice No. 2016-125, Partially Amended and Enforced on Nov. 21, 2016]
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Regulation on Good Manufacturing Practices (GMP) for Medicinal Products.pdf
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[Annex 17] Manufacture of Drug Products.pdf
2019-01-24 -
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23Designation, Specification and Test Method of Tar Colors in Pharmaceuticals, etc.Designation, Specification and Test Method of Tar Colors in Pharmaceuticals, etc. [Ministry of Food and Drug Safety Notice No. 2016- 87, Partially Amended and Enforced on Aug. 23, 2016]
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Designation, Specification and Test Method of Tar Colors in Pharmaceuticals, etc..pdf
2019-01-24 -
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22Regulation on Fees for Pharmaceutical Approval, etc.Regulation on Fees for Pharmaceutical Approval, etc. [Ministry of Food and Drug Safety Notice No. 2016-129, Partially Amended and Enforced on Nov. 30, 2016]
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Regulation on Fees for Pharmaceutical Approval, etc..pdf
2019-01-24 -
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21Designation of Pharmaceuticals Required securing Pharmaceutical EquivalenceDesignation of Pharmaceuticals Required securing Pharmaceutical Equivalence [Ministry of Food and Drug Safety Notice No. 2016-136, Partially Amended and Enforced on Aug. 12, 2016]
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Designation of Pharmaceuticals Required securing Pharmaceutical Equivalence.pdf
2019-01-24 -
