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MFDS Achieves Highest Maturity Level in Regulatory System by WHO 2022.12.02

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MFDS Achieves Highest Maturity Level in Regulatory System by WHO Korea achieves WHO's highest level in Pharmaceutical Re...
- 221130_의약품 규제 시스템 WHO 평가 최고등급 GBT_영문.jpg
- 의약품 규제 시스템 WHO 평가 최고등급 GBT(1MB 이하)_영문.jpg
[Australia] Science Strategy (2017-07-19) 2017.07.20

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To ensure that FSANZ is undertaking high quality science, FSANZ implements a Science Strategy which outlines a strategic...
[USA] Alaska senator introduces GE salmon labeling bill (2017-07-18) 2017.07.19

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An Alaska senator has introduced new legislation to mandate genetically engineered salmon (GE) labelling amid the years-...

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Our Work - Food

Total 69건

Regulation on Recognition of Functional Ingredient and of Standard·Specification for Health Functional Foods (No. 2021-66) 2025.01.23

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Regulation on Recognition of Functional Ingredient and of Standard·Specification for Health Functional Foods (No...
- Regulation on Recognition of Functional Ingredient and of Standard·Specification for Health Functional Foods (No.2021-66).pdf
Haitai Confectionery and Foods 2016.12.16

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1. Business: (1) Biscuit (2) Cracker (3) Snack (4) Gum (5) Candy (6) Ice Cream and Dumpling 2. Exporting Country: ...
- Haitai Confectionery and Foods.pdf
Novarex 2016.12.16

HOME>Our Works>Food>ProductsLink

1. Business: (1) Dietary Supplements(Vitamin, Probiotics, Omega-3, Saw palmetto, Eye health and Beauty, Weight managemen...
- Novarex.pdf

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Our Work - Drugs

Total 106건

Korean Pharmacopoeia (Twelfth Edition) 2024.01.31

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Korean Pharmacopoeia (Twelfth Edition)
- 01_KP Cover.pdf
- 02_[Appendix 1] General Notices.pdf
- 03_[Appendix 2] General Requirements for Pharmaceutical Preparations.pdf
- 04_[Appendix 3] Monographs_Part1.pdf
- 05_[Appendix 4] Monographs_Part2.pdf
- 06_[Appendix 5] General Tests.pdf
- 07_[Appendix 6] General Information.pdf
- 08_Index.pdf
DAE HWA PHARMACEUTICAL CO., LTD. 2016.05.25

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1. Business : DHP-107 oral solution(Paclitaxel) KEBANON plaster(Ketoprofen) LOXONA plaster & Cataplasma(Loxoprofe...
- Attachment 1 (Company profile).pdf
- Attachment 2 (DHP107).pdf
- Attachment 3 (Kebanon, Loxona).jpg
- Attachment 4 (Resnalin).pdf
- Attachment 5 (Flospan).pdf
- Attachment 6 (Gastric).pdf
- image (A).jpg
- image (B).jpg
- image (C).jpg
- image (D).jpg
Daewon pharm. Co., Ltd. 2016.05.25

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1. Business : Renamezin capsule(Spherical Carbon Adsorbent ) Oramin capsule (Multivitamins with Korean Ginseng ) Wont...
- Attachment 1.pdf
- Attachment 2.pdf
- Attachment 3.pdf
- Attachment 4.pdf
- Attachment 5.pdf
- 수출정보작성양식.hwp

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Our Work - Bio&Cosmetics

Total 116건

Guideline on Establishment of Chemical Profiles for Herbal Medicinal Products (English version) 2024.05.21

HOME>Our Works>Bio&Cosmetics>Regulations>Biological Products / Herbal Medicines / Quasi-DrugsLink

Guideline on Establishment of Chemical Profiles for Herbal Medicinal Products (English version)
- Guideline on Establishment of Chemical Profiles for Herbal Medicinal Products (English version).pdf
(Cell therapy products) ANTEROGEN 2017.02.15

HOME>Our Works>Bio&Cosmetics>Manufactures>Biological ProductsLink

Company Information 1. Name ANTEROGEN 2. Website Address http://www.anterogen.com 3. Location (Namsung Plaza, Gasa...
(Biologics) Korea Vaccine Co. Ltd. 2016.10.14

HOME>Our Works>Bio&Cosmetics>Manufactures>Biological ProductsLink

Company Information 1. Name Korea Vaccine Co. Ltd. 2. Website Address http://www.koreavaccine.com 3. Location 44, ...

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Our Work - Medical Devices

Total 213건

Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs 2024.12.11

HOME>Our Works>Medical Devices>RegulationsLink

한국(MFDS)-싱가포르(HSA) 인공지능 의료기기의 임상시험 수행을 위한 지도 지침 ( MFDS-HSA) Guiding Principles for conducting Clinical Trial for Mach...
- Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs_MFDS-HSA.pdf
DRTECH 2016.04.22

HOME>Our Works>Medical Devices>ProductsLink

[ Company Information ] □ Name : DRTECH □ Company CI : □ Website Address (URL) : http://www.drtech.co.kr/en/ □ Loc...
MediFirst 2016.04.22

HOME>Our Works>Medical Devices>ProductsLink

[ Company Information ] □ Name : MediFirst □ Company CI : □ Website Address (URL) : http://medifirst.co.kr/en/ □ L...

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Our Work - Etc

Total 49건

(Apr 2025)Notification on Newly Updated Inspection Order Item for Imported Food Products 2025.04.10

HOME>Our Works>Management of Testing and Inspection Agencies>Foreign Testing Laboratory>Foreign Testing Laboratory ListLink

Please refer to the attached official notification and other documents for the newly updated Inspection Order list. The...
- (ENG)Inspection Order Notification April 2025.pdf
- INSPECTION ORDER NOTIFICATION(2025.4).docx
- 검사명령서(제2025-7호).pdf
Notice on the designation of additional test items for imported food products 2021.11.19

HOME>Our Works>Management of Testing and Inspection Agencies>Foreign Testing Laboratory>Foreign Testing Laboratory ListLink

According to 「REGULATION ON IMPORTED FOOD PRODUCTS SUBJECT OF TESTING AND INSPECTION INSTRUCTION」(MFDS Notification No. ...
- INSPECTION ORDER NOTIFICATION(2021.11.).pdf
Year 2021 E-Newsletter for Foreign Testing Laboratory 2021.12.17

HOME>Our Works>Management of Testing and Inspection Agencies>Foreign Testing Laboratory>Foreign Testing Laboratory ListLink

We have published the E-newletter for Year 2021. The hard copies have been sent to every Foreign Testing Laboratories. ...
- E-Newletter for Year 2021.pdf

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About MFDS

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