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MINISTRY OF FOOD AND DRUG SAFETY. Your safety is our standard. Our Works. Food. ... Korea MFDS and Singapore HSA sign the Mutual Recognition Agreement on GMP for Medicinal Products 2024-02-27 [Press Release] Korea MFDS and U.S. FDA Lead Global Discussion on Advancing 2024-02-21; more News and Notice more information.
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The Republic of Korea’s Ministry of Food and Drug Safety...
- Our Works
Therefore, safety management is being expanded and...
- About MFDS
The Food and Drug Safety Administration was newly...
- COVID-19
(3.28) Pfizer COVID-19 Vaccine Comirnaty Lot Release...
- International Cooperation
Collaborating with international partners are one of the...
- Drugs
1.Application of BE protocol 2.Protocol Approval 4.Generic...
- Bio&Cosmetics
Biopharmaceuticals and Herbal Medicines Bureau...
- Medical Devices
MFDS requires the submission of 'Technical Documents' for...
- Information
27 mar 2023 · Regulation on Good Manufacturing Practices (GMP) for Medicinal Products (No.2021-87, Nov 4,2021).pdf Download. Division 의약품품질과. Written by 김라다. Telephone 043-719-2770. Previous. List. Next. 187, Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea [28159] Tel : +82-43-719-1564 (for ...
(1) If the certificate of GMP compliance is issued for the first time, its expiration date shall be three years from the date of issue. (2) If GMP compliance is assessed to extend the expiration date of the initial certificate of GMP compliance, the expiration date shall be three years from the date on which the inspection
The Korean Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), is the main regulatory body for drugs, medical devices, food, and cosmetic products, that oversees the clinical trial in South Korea.
8 sie 2023 · At the beginning of COVID-19, the on-site audit was temporarily replaced by a document audit, which requires strict and detailed document procedures. 1,2 As of January 2023, Korea has switched back to on-site audits, and there is a long waiting list to get an audit date.
Extended drug GMP certificates are valid for three years from the day of a GMP inspection. However, if a GMP assessment takes place because of changes to a product, the expiry date of the certificate is not affected.
Manufacturers and suppliers intending to sell or import medical devices in South Korea must first obtain approval from the Ministry of Food and Drugs Safety (MFDS). Typically, both domestic and foreign manufacturers of imported medical devices are subject to GMP audit.
