Total 44Articles, Present Page 1/5
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44Manufacturing and Marketing Control Rules for Biologics， etc. (Ordinance of the Prime Minister No. 1717, Jul. 16, 2021)Manufacturing and Marketing Control Rules for Biologics， etc. (Ordinance of the Prime Minister No. 1717, Jul. 16, 2021)
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Manufacturing and Marketing Control Rules for Biologics， etc. (Ordinance of the Prime Minister No. 1717, Jul. 16, 2021).pdf
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[Form 1] Lot Release Certificate for Biologics， etc_Manufacturing and Marketing Control Rules for Biologics， etc.pdf
2023-05-31 -
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43(Advanced Biopharmaceutical Products) Guideline on Quality Assessment for Gene-editing Based Advanced Therapy Medicinal ProductsThis is an English verion of the Korean guideline. You can find the original Korean guideline in the following webpage. https://www.nifds.go.kr/brd/m_15/view.do?seq=12624&srchFr=&srchTo=&srchWord=%ED%8E%B8%EC%A7%91&srchTp=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&...
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Guideline on Quality Assessment for Gene-Editing Based Advanced Therapy Medicinal Products.pdf
2020-12-24 -
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42(Advanced Biopharmaceutical Products) Guideline on Nonclinical Assessment for Gene Therapy ProductsThis is an English version of the Korean guideline. You can find the original Korean guideline in the following webpage. https://www.nifds.go.kr/brd/m_15/view.do?seq=11915&srchFr=&srchTo=&srchWord=%EC%9C%A0%EC%A0%84%EC%9E%90%EC%B9%98%EB%A3%8C%EC%A0%9C&srchTp=0&itm_seq_2=0&...
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Guideline on Nonclinical Assessment for Gene Therapy Products.pdf
2020-12-24 -
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41(Quasi-drugs) Guideline for Measurement Method of Harmful Ingredients in Cigarette-type Smoking Craving SuppressantGuideline for Measurement Method of Harmful Ingredients in Cigarette-type Smoking Craving Suppressant(October 2012)
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9_Guideline_for_Measurement_Method_of_Harmful_Ingredients_in_Cigarette-type_Smoking_Craving_Suppressant.pdf
2017-08-17 -
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40(Quasi-drugs) Guideline to Efficacy Test Method of Mite RepellentGuideline to Efficacy Test Method of Mite Repellent(December 2015)
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8_Guideline_to_Efficacy_Test_Method_of_Mite_Repellent.pdf
2017-08-17 -
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39(Quasi-drugs) Guideline to Efficacy Evaluation of Mosquito RepellentGuideline to Efficacy Evaluation of Mosquito Repellent(August 2015)
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7_Guideline_to_Efficacy_Evaluation_of_Mosquito_Repellent.pdf
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7_Guideline_to_Efficacy_Evaluation_of_Mosquito_Repellent.pdf
2017-08-16 -
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38(Quasi-drugs) Evaluation Guideline for Sterile Quasi-DrugsEvaluation Guideline for Sterile Quasi-Drugs(August 2016)
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6_Evaluation_Guideline_for_Sterile_Quasidrugs.pdf
2017-08-16 -
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37(Quasi-drugs) Guideline on Establishment of Test Item in Preparation of Standards and Analytical Methods of Quasi-DrugsGuideline on Establishment of Test Item in Preparation of Standards and Analytical Methods of Quasi-Drugs (August 2016)
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5_Guideline_on_Establishment_of_Test_Item_in_Preparation_of_Standards_and_Analytical_Methods_of_QuasiDrugs.pdf
2017-08-16 -
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36(Quasi-drugs) Regulation on Classification Code of Quasi-DrugsRegulation on Classification Code of Quasi-Drugs [MFDS Published Ruling No. 68 (Enacted on May 15, 2015)]
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4_Regulation_on_Classification_Code_of_Quasidrugs.pdf
2017-08-16 -
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35(Quasi-drugs) Regulation on Labels of Quasi-DrugsRegulation on Labels of Quasi-Drugs [MFDS Notification No. 2016-114(Revised on Oct. 12, 2016)]
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3_Regulation_on_Labels_of_QuasiDrugs.hwp
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3_Regulation_on_Labels_of_QuasiDrugs.pdf
2017-08-16 -