Ministry of Food and Drug Safety
South Korean regulator and ICH member; applies KGMP requirements.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT MFDS COVERS
The Ministry of Food and Drug Safety (MFDS) is South Korea’s regulator for medicines, medical devices, food, and cosmetics. It administers Korean Good Manufacturing Practice (KGMP) for medicines under the Pharmaceutical Affairs Act and its implementing rules on the safety of pharmaceuticals, making KGMP conformity a condition of manufacturing and import approval.
WHAT MFDS PUBLISHES
- 01KGMP requirements and the MFDS notifications that maintain them
- 02Guidelines interpreting the Pharmaceutical Affairs Act and its regulations
- 03Manufacturing and import approval decisions
- 04Recall and enforcement information
- 05English-language summaries of key regulations and international-cooperation activity
HOW ITS REQUIREMENTS BITE
MFDS assesses GMP conformity through documentary review and on-site inspection, both before approval and during a product’s commercial life, and its approvals are tied to that conformity. As a member of PIC/S and a regulatory member of ICH, MFDS operates its inspection programme in line with the international schemes and can rely on their frameworks when assessing sites, including foreign manufacturers of products imported into Korea.
What practitioners get wrong
- KGMP is aligned with the PIC/S GMP Guide, so evidence prepared for other PIC/S authorities maps across — but the binding text is the Korean instrument.
- MFDS is an ICH regulatory member, so the ICH Q-series applies; treat ICH Q7 onward as part of the expectation, not optional reference.
- Primary regulatory texts are published in Korean; English summaries help, but confirm requirements against the Korean instrument that governs.
- A foreign site making a product imported into Korea must meet KGMP and may be assessed directly by MFDS, not only through its home regulator.
What an inspection under this authority actually probes
WHERE IT SITS INTERNATIONALLY
MFDS joined PIC/S in July 2014 and became an ICH regulatory member in 2016, later joining the ICH Management Committee. Those memberships keep KGMP converged with the PIC/S GMP Guide — which mirrors EU GMP — and with the ICH quality guidelines.
MFDS STANDARDS SPEQ DECODES · 1
DISCIPLINES IN MFDS’S REMIT
MFDS: frequently asked questions
Reference answers on Ministry of Food and Drug Safety’s mandate, what it publishes, and how its requirements acquire force.
What is KGMP and who administers it?
KGMP is Korean Good Manufacturing Practice, administered by the Ministry of Food and Drug Safety (MFDS) under the Pharmaceutical Affairs Act. Conformity is a condition of manufacturing and import approval and is maintained in alignment with the PIC/S GMP Guide.
Is Korea in PIC/S and ICH?
Yes to both. MFDS joined PIC/S in July 2014 and became an ICH regulatory member in 2016, which is why KGMP tracks the PIC/S GMP Guide and the ICH quality guidelines.
Does MFDS inspect foreign manufacturers?
It can. A foreign site making a product imported into Korea must meet KGMP, and MFDS may assess that conformity through documentary review or on-site inspection.