A Shift in the Standards of Herbal Medicine Quality Control

Quality control for herbal medicinal materials is shifting from methods that relied on the experience of skilled practitioners to data-driven and molecular-level verification. To reduce the risk of source-species mixing and misidentification, the Ministry of Food and Drug Safety established standard procedures for developing genetic analysis methods, systematizing DNA-based testing criteria, and at the same time expanded an AI inspection system that helps with visual identification, completing model development for 297 items.

This change arose from a structural limitation: once herbal materials are dried and cut, they are difficult to distinguish by sight alone. As the basis for inspection becomes more quantifiable, disputes at the distribution stage can be reduced, and manufacturers are also required to bear clearer responsibility for raw material selection and incoming goods control.

Reorganizing Manufacturing Processes and Approval Procedures

At manufacturing sites, the system is being revised in a way that incorporates modern equipment even into traditional formulations. The Ministry of Food and Drug Safety explained to the industry the approval procedures resulting from changes to the definition of standard decoctions, seeking to bring processes such as pressurized and reflux extraction under institutional oversight, while at the same time pursuing legal accountability in cases where even basic licensing requirements were ignored, such as the case involving 8.4 tons of illegal herbal materials found to have been produced without authorization.

Rather than representing a trend toward deregulation, this is closer to a process of realigning manufacturing realities with the regulatory framework. While it opens a path for lawful process changes, it also sends a clear signal that production without product approval and quality documentation will no longer be tolerated as common practice.

Localization and Stable Supply of Natural Raw Materials

On the raw material supply side, research is progressing simultaneously to reduce dependence on imports and the limitations of wild harvesting. In South Gyeongsang Province, two new varieties of Trichosanthes kirilowii have been developed to improve productivity and uniformity; in the research community, tissue culture has helped establish a foundation for the localization of Asarum; and through international joint research, the possibility of alternative production of two species of Ungernia has also been confirmed.

This trend reflects the fact that as the natural products industry grows, raw material standardization and sustainability become core elements of competitiveness. Stable propagation technologies and variety development must support efforts to reduce quality variations in pharmaceutical and health functional food ingredients, while also enabling supply chains to be designed without ecological damage.

A Higher Bar for the Functional Products Market

Verification standards are becoming even stricter at the stage of moving into health functional foods. Through minutes showing that it recently reviewed 18 cases, the Health Functional Food Deliberation Committee reaffirmed the principle that statistical differences in only some indicators are not sufficient, and that subject selection, measurement methods, and consistency of results must also all be satisfied for functionality to be recognized.

This tightening of standards can be seen as a measure to prevent exaggerated competition in the market as the number of natural material-based ingredients increases. For companies, it brings the burden of greater development costs and longer timelines, but in the long run it is likely to reshape the market in a direction that filters out weakly supported ingredients and leaves only trustworthy products.