Total 54Articles, Present Page 3/6
-
34(Quasi-drugs) Regulation on Re-evaluation of Quasi-DrugsRegulation on Re-evaluation of Quasi-Drugs [MFDS Notification No. 2015-91, (December 4, 2015, enacted)]
-
2_Regulation_on_Re-evaluation_of_QuasiDrugs.pdf
-
2_Regulation_on_Re-evaluation_of_QuasiDrugs.pdf
2017-08-09 -
-
33(Quasi-drugs) Standard Manufacturing Practice of Quasi-DrugsStandard Manufacturing Practice of Quasi-Drugs [MFDS Notification No. 2016-95(Revised on August 31, 2016)]
-
1_Standard_Manufacturing_Practice_of_QuasiDrugs.hwp
-
1_Standard_Manufacturing_Practice_of_QuasiDrugs.pdf
-
1_Standard_Manufacturing_Practice_of_QuasiDrugs.pdf
-
1_Standard_Manufacturing_Practice_of_QuasiDrugs.pdf
2017-08-08 -
-
32(Biological Products) Regulation on Approval and Review of Biological ProductsRegulation on Approval and Review of Biological Products
-
Regulation on Approval and Review of Biological Products.pdf
2017-04-11 -
-
31(Herbal Medicine) Regulation on Approval and Notification of Herbal (crude) Medicinal Preparations, Etc.[Enforced 2015.9.21.] MFDS Notification No. 2015-63, September 21, 2015, Partially revised]
-
Regulation_on_Approval_and_Notification_of_Herbal_(crude)_Revised.hwp
-
Regulation_on_Approval_and_Notification_of_Herbal_(crude)_Revised.pdf
2016-10-11 -
-
30(Biological Products) 2015 Annual Report of National Lot Release2015 Annual Report of National Lot Release (Issue date : 2016.8)
-
2015 Annual Report of National Lot Relaease.pdf
2016-09-30 -
-
29(Biological Products) Guidleine on National Lot ReleaseGuidleine on National Lot Release (2016.9)
-
Guidleine on National Lot Release (2016.9).pdf
2016-09-30 -
-
28(Common) Regulation on Fees for Pharmaceutical Approval and etc.Regulation on Fees for Pharmaceutical Approval and etc. [MFDS Notification No. 2015-65 (Amended on September 24, 2015)]
-
Regulation_on_Fees_for_Pharmaceutical_Approval_and_etc.pdf
2016-09-26 -
-
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 -
