MFDS's AI Drug Review System at a Glance
Korea's Ministry of Food and Drug Safety (MFDS) is building an AI drug review system that will take over parts of the approval review. A project task force launched in February 2026, and the program will receive KRW 22.3 billion over three years (2026–2028).
The February announcement named "incremental modified drugs" as the 2027 target, while the September budget proposal says "biologics and data-submission drugs." Incremental modified drugs fall under the data-submission category, so the two statements don't really conflict. Still, check MFDS's final announcements to confirm the actual scope and timing.
What Matters for Companies: AI Self-Check Before Submission
The most direct change for companies is an industry support tool. It is being developed alongside the review system so that applicants can check their submissions for format and requirement errors before filing.
Deficiency letters often come from basic mistakes rather than scientific issues: missing forms, mismatched specifications, and numbers that disagree across modules. When AI catches these errors first, reviewers can focus on the substance. MFDS is also aiming for a review timeline of about 240 days, so each round of deficiency responses costs relatively more. A single round can delay approval by months, which puts both launch timelines and funding plans at risk.
Machine-Readable Dossiers Get Through First
Readiness Checklist for Pharma and Bio SMEs
A Word of Caution: AI Does Not Replace Judgment
In the early stages, AI is an assistive tool, and reviewers still make the final call. Passing a self-check means your format is compliant. It does not prove your science is sound. Before uploading materials to the self-check tool, also read the relevant notices on how trade secrets and data security will be protected.
How KITIM Supports Regulatory Readiness
KITIM helps pharma and bio SMEs prepare for approval. We run pre-submission gap assessments, review consistency across CTD modules, and connect companies with government regulatory support programs. If you want to review your submission practices before AI review expands, contact the KITIM consulting team. We will propose practical steps that fit your products and timelines.