Key Changes in MFDS GMP Regulatory Reform for 2026
In 2026, Korea's Ministry of Food and Drug Safety (MFDS) is dramatically simplifying pre-GMP evaluation documentation and launching a raw material manufacturing site certification pilot. For bio SMEs, this opens a dual opportunity: reduced regulatory costs and stronger export competitiveness.
Pre-GMP Submission Documents: From 11 to 4
Previously, pre-GMP evaluation required 11 separate document types, including facility overviews, hygiene standards, quality control manuals, manufacturing control manuals, equipment lists, organizational charts, and process validation reports. The 2026 revision consolidates these into 4 documents: a general site overview, an integrated quality and manufacturing management summary, a key validation summary, and a self-inspection report.
CDMO Special Act and Export Manufacturing Registration
Subordinate regulations under the CDMO Special Act are set for implementation in the second half of 2026. A new export-only pharmaceutical manufacturing registration system will allow production for export with GMP certification alone, without requiring domestic marketing authorization. Combined with simplified pre-GMP procedures, this significantly lowers market entry barriers for new CDMO companies.
Strategies for the Raw Material Certification Pilot
Pilot Scope and Certification Process
The raw material manufacturing site certification pilot targets domestic facilities producing active pharmaceutical ingredients (APIs) and key intermediates. The process consists of document review (approximately 60 days), on-site inspection (2–3 days), and certificate issuance (valid for 3 years). During the pilot period, certification fees are reduced by 50%.
Practical Impact on Finished Product Approvals
When using raw materials from a certified manufacturing site, documentation related to raw materials is waived during finished product approval review. This typically shortens review timelines by 45–60 days on average — a benefit that compounds for companies producing multiple products from the same API source.
Global GMP Trends and Domestic Alignment
The European Medicines Agency (EMA) will tighten API GMP requirements starting December 2026, mandating Written Confirmation of GMP compliance for all APIs distributed within the EU. Korea's raw material certification program is expected to serve as a foundation for mutual recognition arrangements with EMA standards.
Practical Checklist for Bio SMEs
Writing Tips for the 4 Simplified Documents
Transition for Companies with Existing GMP Certificates
Companies with valid GMP certificates will automatically transition to the simplified format at renewal. However, those scheduled for renewal within 2026 should confirm with MFDS in advance whether the new format applies to their submission.
Leveraging the Bio Raw Materials User Testing Support Program
The Ministry of Trade, Industry and Energy's Bio Raw Materials User Testing Support Program (2026 budget: KRW 15.6 billion) covers up to 70% of quality verification costs for domestically sourced raw materials. When combined with the raw material certification pilot, companies can significantly reduce costs from quality verification through certification.
KITIM Consulting — GMP Certification Advisory and Regulatory Support
KITIM provides end-to-end consulting from GMP documentation preparation to on-site inspection readiness and raw material certification pilot participation strategy. Our practical support includes submission document coaching aligned with the simplified pre-GMP requirements, mock self-inspections, and validation document reviews to maximize your certification success rate. For expert guidance on GMP certification and bio regulatory affairs, please reach out through KITIM Contact Us.