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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
[EU] COMMISSION REGULATION (EU 2017/1495) (2017-08-24) 2017.08.28

HOME>Information>International Risk InformationLink

amending Regulation (EC) No 2073/2005 as regards Campylobacter in broiler carcases (Text with EEA relevance) THE EUROP...
[USA] FDA Releases Compliance Guide for Small Business under FSMA Intentional Adulteration Rule (2017-08-24) 2017.08.28

HOME>Information>International Risk InformationLink

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the ...

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Our Work - Food

Total 57건

Food Code (No.2021-54, 2021.6.29.) 2022.06.07

HOME>Our Works>Food>RegulationsLink

1. The translated document herein reflects the Ministry of Food and Drug Safety Notification(No.2021-54, 2021.6.29.) 2....
- ☆Food Code(No.2021-54).zip
Lotte Confectionery Company 2016.07.04

HOME>Our Works>Food>ProductsLink

1. Business : Confectionery (Gum, Chocolate, Candy, Biscuit, Ice cream, Pie, Snack) Health food, Bakery Representative ...
- ●LotteConfectionery_Company_Introduction (롯데제과).pdf
Lotte Foods 2016.12.16

HOME>Our Works>Food>ProductsLink

1. Business: (1) Oil&Fats(Magarine, Butter, Shortening, Cooking Oil, Wipped Cream, Emulsified Fats etc.) (2) Ice Cr...
- Lotte Foods.pdf

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Our Work - Drugs

Total 105건

Regulations on the Criteria for Classification of Drugs(MFDS Notification No.2019-55, July 1, 2019) 2023.05.31

HOME>Our Works>Drugs>RegulationsLink

Regulations on the Criteria for Classification of Drugs(MFDS Notification No.2019-55, July 1, 2019)
- Regulations on the Criteria for Classification of Drugs(MFDS Notification No.2019-55, July 1, 2019).pdf
- [Form 1] Application for Classification of Drugs_Regulations on the Criteria for Classification of Drugs.pdf
DAE HWA PHARMACEUTICAL CO., LTD. 2016.05.25

HOME>Our Works>Drugs>ProductsLink

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 110건

Manufacturing and Marketing Control Rules for Biologics, etc. (Ordinance of the Prime Minister No. 1717, Jul. 16, 2021) 2023.05.31

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

Manufacturing 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).pdf
- [Form 1] Lot Release Certificate for Biologics, etc_Manufacturing and Marketing Control Rules for Biologics, etc.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 200건

Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19 2020.11.04

HOME>Our Works>Medical Devices>RegulationsLink

Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
- Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19.pdf
Hanil Science Inc. 2016.04.21

HOME>Our Works>Medical Devices>ProductsLink

[Company Information] □ Name : Hanil Science Inc. □ Company CI : attachment 1 □ Website Address (URL) : www.ihanil.c...
- attachment1.png
- attachemnt2.pdf
- attachment3_1.jpg
- attachment3_2.jpg
- attachemnt4_1.pdf
- attachment4_2.pdf
Humasis Co., Ltd. 2016.04.21

HOME>Our Works>Medical Devices>ProductsLink

[Company Information] □ Name : Humasis Co., Ltd. □ Company CI : attachment 1 □ Website Address (URL) : www.humasis.c...
- Attachment1.jpg
- [HUMASIS] 2016 Products Brochure(low).pdf
- Attachment1.jpg
- attachment 2.pdf
- product 1 - attachment 3.png
- Product 2 - Attachment 3.jpg

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Our Work - Etc

Total 21건

Notice on the designation of additional test items for imported food products(Dec. 2022) 2022.12.22

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(2022.12.5)1.pdf
List of MFDS-designated Foreign Testing Laboratories 2018.08.20

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

Please refer to the attachment to see the list of Foreign Testing Laboratories for reference.
- List of Designated Foreign Testing Laboratories_180817.xls
Notification on a newly designated Foreign Testing Laboratory(Taiwan) 2018.07.23

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

Taiwan Agricultural Chemicals and Toxic Substances Research Institute ( Wen-Chi Fei ) has been newly designated as a...
- Notification_of_a_new_FTL_No.2018_310.pdf

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About MFDS

Total 7건

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