Building on the momentum of recent high-level engagements with health agencies from around the world, USP hosted a delegation from the Republic of Korea’s (South Korea) National Institute of Food and Drug Safety Evaluation (NIFDS) at our U.S. hub in Rockville, MD. The visit was a platform for collaborative scientific knowledge sharing between NIFDS and USP staff on quality standards development and use. It follows a series of significant interactions with this country that is a critical part of the global medicines supply chain, including the April 2023 state visit of President Yoon Suk Yeol of the Republic of Korea to the U.S. capital region.
During that April visit, USP had the honor of welcoming the head of Korea's Ministry of Food and Drug Safety (MFDS) Dr. Oh Yu-Kyoung for an in-person discussion on the medical product supply chain in Korea and the broader Asia-Pacific region. NIFDS is an affiliate agency working under the MFDS. This meeting coincided with the Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue hosted by USP and co-sponsored by the U.S. Food and Drug Administration and USP.
This summer’s scientific staff exchange represents the fulfillment of a strategic agreement between USP and Minister Oh to deepen our information sharing and continually strengthen our international collaborations. The visit also provides us an opportunity to reflect on the key learnings from my fireside chat with Minister Oh last year and how our partnership can continue in the future. During my fireside chat with MFDS Minister Dr. Oh Yu-Kyoung, at the APEC event, Minister Oh highlighted several policy measures her nation has implemented to enhance the resilience of its medical product supply chain, particularly in times of crisis, including:
- Encouraging domestic production of critical medicines and medical supplies through government pricing recommendations and incentives;
- Establishing a risk-based approach to quality control and product testing to prioritize high-risk products and ensure timely market access for safe and effective medicines;
- Improving timely communication among stakeholders through the MFDS’ medical product monitoring initiative and ensuring early notice (60 days) on the discontinuation of a drug’s production by manufacturers; and
- Stockpiling some national essential products.
Below is a summary of our conversation.
Please share the role that your agency plays in ensuring medical product safety in the Republic of Korea, and the challenges you have experienced as a regulatory agency?
MFDS is a regulatory body responsible for the safety of a range of items from food and pharmaceuticals to cosmetics and medical devices. Along with protecting the health and safety of our people, a large part of our efforts are dedicated to solving large-scale challenges related to medical supply chain issues.
For example, during COVID-19, there were supply issues for certain medical products. One specific challenge was the shortage of prescribed acetaminophen in Korea. To counteract the shortage, MFDS acted quickly and enacted several new and targeted strategies, including encouraging medical doctors to prescribe alternative medicines with similar benefits and working with industry manufacturers to monitor weekly production and inventory. This led to the recognition that the cost of production for domestic manufacturers was not financially sustainable. So, to incentivize domestic production, the cost of prescribed acetaminophen was raised – something that had not been done in many years.
What other activities are taking place in Korea today to improve the resilience of the medical product supply chain?
Following the learnings from that essential medicine shortage, MFDS implemented three strategies to ensure the resilience of the medical supply chain. These include:
- A pre-reporting system that requires manufacturer notification 60 days prior to their discontinuation of manufacturing, to allow time for substitute products to be acquired;
- Committee meetings to ensure consistent communication with stakeholders who work closely with the Korea Medical Products Monitoring Center; and
- Stockpiling of national essential drug products by both the government and manufacturers.
How does MFDS engage with the many stakeholders that you work with?
Our team is diligent about maintaining consistent communication with manufacturers and other key stakeholders. We prioritize check-ins with stakeholders such as the Association of Medical Doctors and the Association of Pharmaceutical Manufacturers and Distributors regarding any issues with production. We meet frequently with CEOs of pharmaceutical manufacturing companies, working together on ways to innovate this industry and proactively develop solutions for potential drug shortages and supply chain issues before they happen. When there is a concern about an upcoming shortage, we carefully evaluate the impact of the potential shortage and collaborate on how to develop alternative strategies to ensure the availability of critical medicines.
Other issues we address with our key stakeholders include the importance of medicine quality, ensuring quality is maintained throughout the entire production process, and best practices related to exporting critical medicines.
What is Korea’s policy or approach for advancing regulatory convergence in general or specifically in the APEC region?
MFDS plays a significant role in advancing regulatory convergence in APEC. For the last 15 years, MFDS has hosted international workshops about regulatory convergence and held in-person training for 400 regional officials in the APEC Harmonization Center (AHC) at MFDS. AHC is responsible for promoting sustainable economic growth and success in the Asia-Pacific region and is designed as a learning center for officials in the APEC region.
As an agency, we are focused on creating efficient guidance and building a solid foundation for advancing regulatory convergence in the APEC region. This effort includes ensuring quality assurance is at the forefront, enhancing regulatory predictability, and working with manufacturers on the distribution of quality medicines.
Last November, MFDS achieved maturity level 4, which is the highest level in the World Health Organization’s classification of regulatory authorities for pharmaceutical products and vaccines, which was a great honor.
Looking ahead, APEC 2025 will be hosted in Korea. What are your team’s plans for that event?
We look forward to hosting this and collaborating with more APEC members. During the event, we will address new areas where regulation is not as solidified, such as medical devices and advanced biologics. MFDS recognizes that lateral and bilateral relationships are all important, and we are interested in collaborating with APEC members on these areas.
We will focus on finding new avenues for innovation, facilitating the trade of innovative products, ensuring quality throughout the manufacturing and production process, and strengthening the resiliency of the global medical supply chain.
Thank you, Minister Oh. Readers can watch the full recording of my conversation with Minister Oh, read more about the sessions at the APEC Medical Product Supply Chain Dialogue or use the web-based APEC supply chain security toolkit.
