Contents of Korean News Letter

Contents of Korean News Letter

intellim's Korean New Letter provides the latest information about clinical trials in Korea, such as amendment of guidelines announced by MFDS (Ministry of Food and Drug Safety). Please contact us at the following form to subscribe.
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Vol Contents Published Dates
24 Examples of bridging study document evaluation have been established.
[IV Example (4) of bridging study document evaluation for new drug]
2015/4/29
23 Examples of bridging study document evaluation have been established.
[IV Example (3) of bridging study document evaluation for new drug]
2015/4/15
22 Examples of bridging study document evaluation have been established.
[IV Example (1) and (2) of bridging study document evaluation for new drug]
2015/3/25
21 Examples of bridging study document evaluation have been established.
[I General Statement – III Current situation of bridging study document evaluation for new drug]
2015/3/11
20 Guideline for clinical trial targeting small group such as rare disease patients 2015/2/26
19 MFDS –Analysis of clinical trial approval situation in 2014 2015/2/9
18 2015 planned changes on food and drug safety system 2015/1/26
17 Administrative Announcement: Draft of Partial Amendment of "Regulation regarding IND approval" 2015/1/26
16 "Relief Scheme for Adverse Drug Reactions" has been implemented. 2015/1/8
15 Regulation on examination of pharmaceutical product item submission is planned to be partially amended. 2014/12/9
14 "Regulation for Implementation of Pharmaceutical Validation" is planned to be partially amended. 2014/11/14
13 Update about "Guideline: Pharmaceutical Certification in English". 2014/11/7
12 "Guideline: Outline of Petition Document Procedure Using Electric Petition System (Pharmaceutical Safety Control System)" has been announced. 2014/10/27
11 "Regulation for Authorization, Declaration and Examination of Medical Devices" is planned to be fully amended. 2014/10/27
10 Material from Briefing Session about "Major Promoting Issues on Pharmaceutical Safety Control Policy" is partially available. 2014/11/7
09 Material from Briefing Session about "Relief Services for Adverse Health Effects" is partially available. 2014/11/12
08 "Evaluation Guideline on Tumorigenicity (Oncogenicity) of Stem Cell Therapy Drug" has been announced. 2014/10/17
07 "Guideline on Examination of Pharmaceutical Product Approval Declaration" has been announced. 2014/10/15
06 "Regulation for Examination of Pharmaceutical Product Approval Declaration" is planned to be partially amended. 2014/10/6
05 "Standard for Equivalence Study" is planned to be partially amended. 2014/10/6
04 "Examination Guideline for Physicochemical Properties of Medical Devises" has been announced. 2014/10/6
03 "Regulation for Orphan Drug Designation" is planned to be partially amended. 2014/10/1
02 "Regulation for IND Approval" is planned to be partially amended. 2014/10/1
01 "Regulation for Basic Document Control on Pharmaceutical Clinical Studies" is planned to be no longer effective. 2014/10/1

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