South Korea’s Ministry of Food and Drug Safety (MFDS) is the national regulator responsible for authorizing drug and biologic clinical trials conducted in the Republic of Korea. For a sponsor planning a Korea site as part of a multi-regional clinical trial, or a Korea-only development program, the MFDS review of a Clinical Trial Plan is the equivalent gate that an FDA Investigational New Drug (IND) application represents in the United States or a PMDA Clinical Trial Notification represents in Japan — run on a broadly similar timeline, but with its own review-division structure, pre-submission consultation option, and a strict requirement that MFDS clearance and Institutional Review Board (IRB) approval both be in hand before a Korea site can enroll its first subject.
This guide covers MFDS’s role and structure, how a Clinical Trial Plan (IND-equivalent) is actually reviewed, the legal framework behind that review, IRB requirements, and the fast-track options available to qualifying sponsors.
What MFDS is and what it governs
MFDS is South Korea’s national food and drug regulatory authority, organizationally positioned as a ministry-level body reporting to the Prime Minister’s Office rather than as a division of the health ministry — a structural point that sometimes surprises sponsors used to jurisdictions where drug regulation sits inside a health department. Within MFDS, clinical trial applications for investigational drugs and biologics are handled by dedicated review divisions covering chemistry/manufacturing/controls (CMC), non-clinical pharmacology and toxicology, and clinical data, with a separate track for biologics; a Clinical Trial Management function coordinates the overall Clinical Trial Plan (CTP) review and any post-authorization protocol amendments.
MFDS authorization of the Clinical Trial Plan is required before an investigational drug or biologic can be administered to human subjects at a Korea-based trial site. This guide covers the drug/biologic pathway; medical device clinical trials in Korea follow a related but separate MFDS process not covered here.
Legal framework: the Pharmaceutical Affairs Act and its Enforcement Rule
Clinical trials in South Korea are governed at the statutory level by the Pharmaceutical Affairs Act (PAA), with the operational detail — what a Clinical Trial Plan application must contain, how MFDS reviews it, and how trial institutions and investigators must be designated — set out in the Act’s implementing Enforcement Rule (published by MFDS as the Regulation on Safety of Pharmaceuticals and other subordinate notifications). Trial conduct itself must additionally follow Korea Good Clinical Practice (KGCP), which is substantively aligned with ICH GCP principles (ICH E6(R2)) but remains its own binding domestic regulation rather than a direct adoption of the ICH text. Sponsors and regulatory affairs teams should treat the primary Korean-language statute and its enforcement rule/notifications, available through MFDS’s own publications, as the authoritative source for current article numbers and specific documentary requirements, since MFDS periodically updates the enforcement rule and associated notifications.
The Clinical Trial Plan (CTP) review process
The MFDS equivalent of an FDA IND is formally called a Clinical Trial Plan (CTP) approval. A sponsor submits the CTP dossier — investigational product CMC data, non-clinical pharmacology/toxicology data, the clinical protocol, the informed consent form, and (for later-phase or already-marketed-elsewhere products) available clinical data — to MFDS, which assigns it across its CMC, non-clinical, and clinical review divisions in parallel.
The standard statutory review period is 30 working days from acceptance of a complete application. As with the FDA IND model, MFDS review operates on an implicit-clearance logic: if MFDS does not raise an objection, request additional information, or place the trial on hold within the review period, the sponsor may proceed. In practice, sponsors and regulatory consultancies report that straightforward applications are often cleared within four to six weeks, while dossiers with CMC or non-clinical gaps, or that draw a request for additional information, can extend well beyond the 30-working-day clock — commonly cited in the two-to-three-month range once clarification cycles are included. A key operational requirement distinct from many other jurisdictions: the trial protocol, informed consent form, and subject compensation plan must be submitted in Korean, and technical CMC/manufacturing sections generally require at least a Korean-language synopsis even where the full technical package is in English.
Since 2019, MFDS has offered a pre-IND (pre-CTP) consultation track, allowing a sponsor to discuss trial design, dossier scope, and anticipated review questions with MFDS reviewers before formal submission. Sponsors who use this consultation and submit a well-aligned dossier afterward are reported to see meaningfully shorter formal reviews in some cases — regulatory-affairs sources describe reviews as short as roughly one to two weeks following a substantive pre-consultation, though this is not a guaranteed outcome and depends on how closely the final submission tracks what was discussed.
IRB approval: a parallel, independent requirement
A Clinical Trial Plan cleared by MFDS does not by itself authorize a trial to begin. Every participating Korean trial site must also obtain approval from its Institutional Review Board (IRB), which reviews the protocol, informed consent process, and subject-protection safeguards independently of MFDS’s scientific and manufacturing review. IRB review in Korea is generally reported to take on the order of three to six weeks, and — importantly for sponsor timeline planning — it can run in parallel with, rather than strictly after, the MFDS CTP review, since the two reviews assess different things (regulatory/scientific sufficiency for MFDS; ethical conduct and participant protection for the IRB). A sponsor cannot enroll the first subject at a Korean site until both approvals are in hand, so the realistic site-activation timeline is set by whichever of the two tracks finishes last, not by the MFDS clock alone.
Fast-track and expedited options
Beyond the pre-CTP consultation described above, MFDS maintains priority-review mechanisms for products addressing serious or rare conditions with unmet medical need, broadly comparable in intent to breakthrough-therapy and orphan-drug expedited tracks in other major jurisdictions — sponsors developing an orphan-designated or breakthrough-eligible product should confirm current eligibility criteria and any associated review-timeline benefit directly with MFDS, since program names and specific timeline commitments are periodically revised. Separately, Korea regulates advanced biological products — cell and gene therapies and other regenerative-medicine products — under dedicated legislation distinct from the general Pharmaceutical Affairs Act pathway used for conventional drugs and biologics; sponsors developing a cell or gene therapy product should confirm at the outset which statutory track (conventional PAA/CTP or the advanced-biologics-specific framework) applies, since the dossier requirements and review body differ.
How this compares to other jurisdictions
For sponsors coordinating a multi-regional trial that includes a Korea site, it helps to see the MFDS pathway alongside the mechanisms it’s most often compared to:
- United States (FDA): a 30-calendar-day implicit clearance for the initial IND — mechanically similar in structure (silence-equals-clearance) to MFDS’s 30-working-day default, though denominated in calendar rather than working days.
- Japan (PMDA): a 30-day initial review window for the Clinical Trial Notification (CTN), Korea’s closest regional comparator both in review length and in the shared expectation of Korean- or Japanese-language submission materials for key documents.
- China (NMPA): see CASRAI’s NMPA Clinical Trial Approval Process guide — NMPA’s default review runs considerably longer (60 working days, with a 30-working-day expedited track for qualifying innovative drugs since late 2025) than MFDS’s standard 30-working-day clock.
- Brazil (ANVISA): see CASRAI’s ANVISA Clinical Trial Approval guide for a Latin American regulatory comparison point.
- Cross-jurisdiction trial design: sponsors running a genuine multi-regional trial spanning Korea alongside the US, EU, Japan, or China should read this alongside ICH M4 (CTD) for how submission dossiers are harmonized across authorities, and ICH M11 for the harmonized protocol template increasingly used across regions including Korea.
Who manages this process
In practice, the MFDS CTP submission is typically owned by a sponsor’s Korea regulatory affairs function or a Korea-based CRO acting on the sponsor’s behalf, working alongside local counsel or a regulatory consultancy for the Korean-language documentation requirements and the site’s IRB for local ethics approval. For a multinational sponsor, the research administration function’s role is usually coordination and timeline planning — sequencing the MFDS CTP review, the parallel IRB approval, and site activation so that language-localization work (a step with no direct equivalent in an English-language-default jurisdiction like the US or UK) doesn’t become the unplanned critical path.
Frequently asked questions
Is MFDS approval the same as an FDA IND?
Functionally comparable — both are the required regulatory authorization before administering an investigational drug to human subjects, and both use an implicit-clearance model where agency silence within the review period allows the sponsor to proceed. FDA’s IND uses a 30-calendar-day clock; MFDS’s Clinical Trial Plan (CTP) approval uses a 30-working-day clock, which in practice runs somewhat longer in calendar time.
How long does MFDS clinical trial approval actually take?
The statutory review period is 30 working days from acceptance of a complete application. Straightforward applications are often cleared in four to six weeks; applications that draw requests for additional information can extend to two to three months. A pre-CTP consultation with MFDS, available since 2019, can shorten the formal review meaningfully for sponsors who use it and submit a well-aligned dossier afterward.
Do I need separate IRB approval if MFDS has already approved the Clinical Trial Plan?
Yes. MFDS clearance and site-level IRB approval are independent requirements, and both must be obtained before the first subject can be enrolled at a Korean site. IRB review generally takes three to six weeks and can run in parallel with the MFDS review rather than waiting for it to finish first.
Does the CTP dossier need to be submitted in Korean?
The trial protocol, informed consent form, and subject compensation plan must be submitted in Korean, and technical CMC/manufacturing sections generally require at least a Korean-language synopsis even when the full technical dossier is prepared in English. Sponsors new to Korea should budget translation and local regulatory-affairs time into their submission timeline, not just the MFDS review clock itself.
What legal framework governs MFDS’s clinical trial review?
The Pharmaceutical Affairs Act (PAA) is the governing statute, with the operational requirements for Clinical Trial Plan applications, review, and trial institution/investigator designation set out in the Act’s Enforcement Rule and associated MFDS notifications. Trial conduct itself must additionally follow Korea Good Clinical Practice (KGCP), which is substantively aligned with ICH GCP but is its own binding domestic regulation.
Key takeaways
- MFDS, Korea’s national drug regulator, reviews Clinical Trial Plan (CTP) applications — the Korean equivalent of an FDA IND — under a 30-working-day default implicit-clearance model.
- The Pharmaceutical Affairs Act and its Enforcement Rule are the governing legal framework; trial conduct additionally follows Korea Good Clinical Practice (KGCP), aligned with but distinct from ICH GCP.
- Site-level IRB approval is a separate, mandatory requirement that can run in parallel with MFDS review — both approvals are required before first-subject enrollment.
- A pre-CTP consultation option, available since 2019, can meaningfully shorten formal review for sponsors who use it.
- Korean-language submission requirements for the protocol, informed consent form, and compensation plan (plus a Korean synopsis of technical CMC data) are a distinct operational burden sponsors from English-default jurisdictions often underestimate.
- Advanced biological products (cell and gene therapies, other regenerative-medicine products) follow separate, dedicated Korean legislation rather than the standard PAA/CTP drug pathway — confirm which track applies before scoping a submission.
