Government to prevent drug supply disruptions amid Middle East tensions

HIRA moves to proactively assess the impact on drug procurement

MFDS lowers threshold for reviews, including packaging changes

Concerned that geopolitical risks in the Middle East could escalate into instability in the drug supply chain, the government is simultaneously pursuing regulatory improvements and conducting a survey of the current supply situation.

This is because logistical disruptions involving raw materials and packaging materials could affect the domestic drug supply. In particular, there are concerns that shortages of petrochemical raw materials, such as naphtha, could exacerbate packaging supply issues.

On the 3rd, the Pharmaceutical Supply Management Division of the Health Insurance Review and Assessment Service (HIRA) launched a survey on pharmaceutical supply status through the Korea Pharmaceutical and Bio-Pharma Manufacturers Association.

The aim is to identify which drugs are being affected by import delays and supply disruptions due to risks in the Middle East. HIRA plans to use this information to proactively prepare countermeasures.

HIRA is monitoring drug distribution inventory levels through the Korea Pharmaceutical Information Center. However, there is a limitation in that, while it has data on domestically distributed drugs, it is difficult to predict supply disruptions caused by import and logistics delays.

HIRA is expected to compile information from pharmaceutical companies, including product names, packaging materials, and inventory levels, by next week and use this as a basis for formulating strategies such as future drug price management and securing alternative medications.

If disruptions in the logistics networks for raw materials and packaging materials persist, the impact on domestic pharmaceutical companies’ production costs and supply stability could increase even further. Consequently, the government appears to be taking preemptive action before supply instability becomes a reality.

The Ministry of Food and Drug Safety also discussed countermeasures last week with three companies supplying basic IV fluids and introduced unprecedented regulatory easing measures, including a fast-track system for approval changes.

The measures were announced on the 3rd during a joint meeting of the Emergency Economic Measures Headquarters Meeting and Ministerial Meeting on Economic Affairs. The government announced regulatory easing measures. The MFDS lowered regulatory barriers to enable pharmaceutical and medical device manufacturers to diversify their supply chains for raw materials and packaging materials, such as IV solutions and syringe needles.

First, in cases where changes to product approval are required due to shortages of petrochemical raw materials such as naphtha, a 'fast-track system' has been newly established to prioritize review over other items.

Additionally, for medical devices, the agency allowed manufacturers to make changes to packaging materials to undergo document reviews instead of on-site GMP inspections.

This is intended to reduce the one to two months it typically takes for pharmaceutical companies to complete product license amendment reviews. The measures to shorten review periods will be implemented immediately as part of the government’s proactive administration initiative.