What Changes in the August 2026 Legislative Notice
The Ministry of Food and Drug Safety (MFDS) has issued a legislative notice for a partial amendment to the Rules on the Safety of Drugs, with the public comment period open until October 21. The direction is unmistakable: a two-way overhaul that lowers administrative burden while tightening quality and safety control.
Minor items such as changes to a listed business address shift from formal license variation to a simple reporting obligation. At the same time, quality control for investigational medicinal products (IMP) and the product recall system become considerably tighter. The problem is that many small and mid-sized pharma and biotech firms notice only the relaxed items and miss the strengthened ones. They relax at the deregulation headline, then get cited during inspection.
Strengthened Quality Standards for Investigational Medicinal Products
IMP manufacturing is fundamentally different from commercial GMP. Batch sizes are small (often hundreds to a few thousand vials), the product mix is wide, and processes change frequently as protocols are amended. The stable, validated process that commercial GMP assumes simply does not exist here.
Where tightening is expected
If you use a CDMO, your Quality Agreement must spell out deviation notification deadlines (for example, within 24 hours of awareness), the sponsor's right to pre-approve process and material changes, audit and inspection attendance rights, and record retention periods (at minimum two years after the final study ends). Anything absent from the agreement ultimately falls back on the sponsor.
For a Phase 1 stage venture, the minimum viable quality system comes down to five SOPs: document control, deviation and CAPA, change control, training, and self-inspection. Without these five, even a CDMO's own qualification audit becomes difficult to pass.
Preparing for a Stronger Recall Framework
A recall follows a fixed sequence: classification, reporting, execution, and closure reporting. Class 1 recalls involving serious health risk require immediate reporting upon awareness, and completion deadlines differ by class. The failure point in practice is always the same: the SOP never specifies who decides what, within how many hours.
What the Shift to Reporting Actually Means
Simplification also means the burden of judgment moves to the company. Misclassifying an item as reportable and thereby omitting a required license variation constitutes unauthorized change manufacturing, exposing you to administrative sanctions such as suspension of manufacturing for that product.
The countermeasure is straightforward. Build a three-way classification table into your change control SOP — license variation / reportable / internal record only — and document a written pre-inquiry to the regional MFDS office for any borderline case. The documented basis for your judgment becomes your defense.
A Phased Preparation Roadmap for SMEs
The time remaining before the October 21 comment deadline is not just preparation time. It is an opportunity to shape the rule. If any provision would place an unreasonable burden on your process, now is the moment to say so.
Working with KITIM
The Korea Institute of Technology Innovation Management (KITIM) supports pharmaceutical and biotech companies with GMP quality system diagnostics, SOP revision advisory, and regulatory change monitoring and response strategy. We also help connect your quality system upgrade to government R&D and certification support programs. If responding to the amended rules feels overwhelming, reach out for a consultation.