[ NATIONAL · KR ]
A single ministry-level authority for food and drug safety, participating in the main harmonizers.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
ASIA-PACIFIC
The Pharmaceutical Affairs Act, together with the Regulation on Safety of Medicinal Products made under it. The national authority administers both, and Korean good manufacturing practice — KGMP — is aligned with the PIC/S guide, the authority having become a PIC/S participant in 2014. The technical content converges with EudraLex Volume 4, so a system built for the European guide is being measured against a familiar text.
Through two permissions that are deliberately coupled. A manufacturer needs a manufacturing business licence and, separately, marketing authorisation for each product it makes. The coupling is the part to plan around: an applicant cannot obtain a manufacturing business licence without simultaneously submitting a marketing authorisation application for at least one product. The site permission and the first product application are one exercise rather than two sequential ones.
WHAT TRANSFERS
Both halves travel further here than in most of the region. Korea participates in ICH and in PIC/S, so the dossier and the inspection outcome are both legible, and KGMP’s convergence with EudraLex Volume 4 means a European quality system maps onto the Korean standard with unusually little translation. The permissions themselves remain Korean, and the site assessment is a real assessment rather than a recognition step.
Because a manufacturing business licence application requires a simultaneous marketing authorisation application, the product selected for that first submission is a strategic choice, not an administrative one. Choosing a complex product couples a site permission to a difficult dossier.
The same ministry-level body covers both. For a borderline product — a supplement, a functional food, a combination — the classification question is answered inside one organisation, and answering it late is expensive.
The convergence is close enough that European procedures usually map across, and different enough that the mapping should be evidenced rather than assumed. Differences tend to sit in local documentation and reporting expectations rather than in the technical standard.
A foreign manufacturer supplying the market is assessed on documentation and may be inspected. PIC/S participation makes prior inspection outcomes meaningful without making them sufficient.
The Pharmaceutical Affairs Act and the Regulation on Safety of Medicinal Products made under it, administered by the national food and drug safety authority. Korean GMP is aligned with the PIC/S guide and converges with EudraLex Volume 4.
No. An applicant must submit a marketing authorisation application for at least one product at the same time as the manufacturing business licence application. The two are coupled by design, so the first product is chosen as part of the site strategy.
Yes — the authority became a PIC/S participant in 2014, and Korean GMP is aligned with the PIC/S guide. Participation supports confidence in inspection outcomes from other participating authorities; it does not replace the Korean permissions.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about South Korea: requirements still arrive through the authorities below, and the edition in force is theirs to state.
Participation changes which evidence transfers, and which edition of a harmonized guide the local instrument is likely to pin.