Growing role of the Korea Orphan & Essential Drug Center

following President Lee's campaign promises

Securing a budget·personnel are the key…reviewing ways to enhance business efficiency

Strives to strengthen on-site monitoring of national essential medicines·emergency imported medicines

"The emergency import of essential medicines through the Korea Orphan & Essential Drug Center (KOEDC) will be expanded, and support for pharmaceutical companies producing domestic products will be planned." President Lee Jae-myung made this pledge on his Facebook page on May 28, during his campaign for the presidency.

 

President Lee emphasized the importance of the KOEDC, stating that he would strengthen national guarantees for the treatment of rare and intractable diseases.

 

However, the KOEDC is a Ministry of Food and Drug Safety (MFDS)-affiliated organization with a fixed quota of only 30 personnel.

 

KOEDC is responsible for the supply of rare and national essential medicines, establishing a stable supply base for national essential medicines, and supporting R&D.

 

The center is currently understaffed.

 

Kim Young-rim, CEO of Korea Orphan & Essential Drug Center (KOEDC)

Kim Young-rim, CEO of KOEDC, stated at a briefing for journalists covering the MFDS on June 17, "The global supply chain has become increasingly important after COVID-19, and the role of the center is also growing." Kim added, "As a small organization with only 30 personnel, where individual roles and responsibilities are significant, it is necessary to devise ways to perform duties efficiently." In particular, the emergency import of essential medicines mentioned by President Lee is part of the national essential drug supply management plans implemented by the KOEDC.

 

The KOEDC plays a crucial role in managing emergency imports of medicines that could be subject to potential supply shortages from overseas, domestically produced products under contract manufacturing, and emergency use authorizations for items deemed necessary to address public health crises.

 

Kim stated, "The KOEDC is a specialized organization responsible for the stable supply of rare and essential medicines in Korea.

 

This year, we plan to actively identify and promote tasks in line with the new government's initiatives to strengthen our role in ensuring a stable supply of rare and essential medicines." Regarding national essential medicines, strengthening on-site supply and demand monitoring, as well as emergency importation of drugs, is one of the main tasks for this year.

 

The goal is to enhance management analysis of discontinued drugs, thereby shortening the designation period for emergency imported drugs and their subsequent domestic entry.

 

Additionally, it aims to prioritize the classification of emergency imported drugs to facilitate appropriate inventory management.

 

The KOEDC's role also includes planning the details for stable supply, such as identifying annual supply and demand plans for drugs requested by government ministries and expanding procurement sources.

 

In addition to national essential medicines, the KOEDC also announced plans for rare diseases this year.

 

Kim said, "For items that have been labeled as essential in areas where no existing treatments were available and have been designated as MFDS GIFT (Global Innovative products Fast Track) and approved, we will temporarily supply them during the domestic supply gap period before drug price negotiations, contributing to increased patient access." They are also planning expedited reimbursement applications for pediatric drugs such as 'Glucagen hypo kit,' 'Baqsimi Nasal Spray,' and 'Rapamune Syrup.' KOEDC is exploring ways to reduce patient burden by converting candidates to tax-exempt status after reviewing relevant provisions.

 

The KOEDC has been conducting the "Research on Establishing a Domestic Stable Supply Base for National Essential Medicines" since 2022 to establish a domestic self-sufficiency base for national essential medicines in response to supply chain crises.

 

Through Phase 1 of the project, conducted from 2022 to 2023, a domestic production base for two finished pharmaceutical products and three active pharmaceutical ingredients (APIs) has been established.

 

Ahn Myung-soo, a division head at the KOEDC, stated, "Myung In Pharm used to import benserazide raw material from China, but we have developed it domestically and completed its DMF registration with MFDS." Ahn added, "While commercialization is a decision for the pharmaceutical company due to drug pricing issues, its significance lies in being registered in the DMF so that it can be used at any time." Furthermore, Korus Pharm's amiodarone injection received approval for export.

 

With additional processing, a push for technology transfer, and further R&D investment, it could become commercialization-ready.

 

Since last year, Phase 2 of the project has been underway, which includes the domestic development of both the API and finished drug for acetaminophen.

 

Ahn added, "We have succeeded in achieving self-sufficiency through the domestic development of the API and finished pharmaceutical product for acetaminophen.

 

A product approval application will soon be submitted to MFDS," and added, "This means that domestic self-sufficiency is possible if there are shortages, regardless of the global supply chain." In this regard, Kim stated, "There are limitations to securing a stable supply network through projects funded by the KOEDC." Kim added, "Budget and personnel support are necessary for these projects to be sustainable within the KOEDC's scope.

 

To achieve this, we plan to work towards this continuously."