Total 47Articles, Present Page 3/5
-
27(Common) Regulation on Safety Information Control of Medicinal ProductsRegulationon Safety Information Control ofMedicinal Products,etc.[Ministry of Food and Drug Safety Notification No. 2014-97, 20.Feb.2014, Partial Amendment]
-
Regulation_on_Safety_Information_Control_of_Medicinal_Products,_etc.pdf
-
[Attached_form_No.1]_Adverse_Event_(AE)_Report_for_Medicinal_Products,_etc.pdf
-
[Attached_Form_No.2]Adverse_Event_(AE)_Report_for_Medicinal_Products,_etc(For_Consumer).pdf
-
[Attached_Form_No.3]Drug_Safety_Surveillance_(Amendment)_Plan_Report.pdf
-
[Attached_Form_No._4]Drug_Safety_Information_Termination_Report.pdf
2016-09-26 -
-
26(Common) Standard for Re-examination of New Drugs, etc.Standard for Re-examination of New Drugs, etc. [MFDS Notification No 2015-79, Oct 30,2015]
-
Standard_for_Re-examination_of_New_Drugs,_etc..pdf
2016-09-26 -
-
25(Common) Regulation on Drug Re-Evaluation ExecutionRegulation on Drug Re-Evaluation Execution[MFDS Notification No. 2014-64 (Feb 12,2014, Partial Amendment)]
-
Regulation_on_Drug_Re-Evaluation_Execution.pdf
-
[Annex_1]Evaluation_Method_and_Criteria_(In_Connection_with_Article_2).pdf
-
[Attached_form_1]Drug_Re-Evaluation_Application.pdf
2016-09-26 -
-
24(Common) Regulation on Stability Test of PharmaceuticalsRegulation on Stability Test of Pharmaceuticals[MFDS Notification No. 2014-59, Feb.12, 2014, Partially Amended ]
-
Regulation_on_Stability_Test_of_Pharmaceuticals.pdf
2016-09-26 -
-
23(Common) Good Manufacturing Practice for investigational medicinal productsGood Manufacturing Practice for investigational medicinal products
-
Good_Manufacturing_Practice_for_investigational_medicinal_products.pdf
2016-09-26 -
-
22(Common) Regulation on Approval for Investigational New Drug Application of DrugsRegulation on Approval for Investigational New Drug Application of Drugs[Ministry of Food and Drug Safety Notification No. 2015-22,Apr 30, 2015]
-
Regulation_on_Approval_for_Investigational_New_Drug_Application_of_Drugs.pdf
2016-09-26 -
-
21(Common) Regulation on Pharmacology Study for PharmaceuticalsRegulation on Pharmacology Study for Pharmaceuticals [MFDS Notification No. 2015- 83(November 11, 2015)]
-
Regulation_on_Pharmacology_Study_for_Pharmaceuticals.pdf
2016-09-26 -
-
20(Common) Good Laboratory PracticeGood Laboratory Practice[Notification No. 2014- 67, Ministry of Food & Drug Safety, 2/12/2014, revised]
-
Good_Laboratory_Practice.pdf
2016-09-26 -
-
19(Common) Standard for Toxicity Study of PharmaceuticalsStandard for Toxicity Study of Pharmaceuticals [MFDS Notification No. 2015- 82(Revised on November 11, 2015)]
-
Standard_for_Toxicity_Study_of_Pharmaceuticals.pdf
2016-09-26 -
-
18(Common) Regulation on Pharmaceutical GMPRegulation on Pharmaceutical GMP[MFDS Notification No. 2015-35 (established on June 17, 2015)]
-
Regulation_on_Pharmaceutical_GMP.pdf
2016-09-26 -