Government Expands Emergency Import System for Rare Medicines | Be Korea-savvy

Government Expands Emergency Import System for Rare Medicines


A view of the main building of the Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. (Image courtesy of the Ministry of Food and Drug Safety)

A view of the main building of the Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. (Image courtesy of the Ministry of Food and Drug Safety)

SEOUL, Jan. 9 (Korea Bizwire) — South Korea will strengthen its public system for supplying essential medicines and medical devices in 2026, seeking to prevent treatment disruptions and reduce patients’ financial burdens, the government said this week.

The Ministry of Food and Drug Safety said it will expand emergency import programs for rare and essential drugs, revive domestic production of critical medicines and tighten oversight of medical device supply chains as part of its annual policy agenda.

Under the plan, medicines that patients have previously had to purchase directly from overseas for personal use will be gradually converted into government-supplied emergency import items through 2030.

The ministry also plans to widen the application of insurance pricing to emergency-imported drugs, easing out-of-pocket costs for patients.

To bolster domestic capacity, the government will step up a made-to-order manufacturing program for national essential medicines, using private pharmaceutical production facilities to restart local output of drugs that are otherwise vulnerable to shortages.

For medical devices at risk of supply disruptions because of discontinued overseas production or limited commercial viability, authorities will introduce faster, government-led emergency import procedures to prevent gaps in care.

The ministry also outlined measures to reinforce supply systems at the clinical level. Lists of essential medicines used in medical settings will be reorganized by therapeutic category, drawing on standards used by the World Health Organization and reflecting changes in clinical practice.

From November, a consultative body overseeing stable supplies of essential medicines will be restructured into a joint public-private governance framework.

In addition, the government plans to introduce a formal definition of “national essential medical devices” and pursue amendments to the Medical Devices Act to allow more systematic management and support.

Devices used for life-sustaining treatment and emergency surgery will be prioritized for localization, with multiple ministries coordinating to support domestic development.

Officials said the expanded framework is aimed at ensuring uninterrupted access to critical treatments in an aging society, while reducing reliance on fragile overseas supply chains and strengthening the resilience of Korea’s healthcare system.

Ashley Song (ashley@koreabizwire.com) 

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