[Asia Exclusive] "COVID-19 Drug Review Period Reduced to 5.7 Days... Fighting Against Time"

Lee Eui-kyung, Director of the Ministry of Food and Drug Safety
Focuses on Balancing Safety and Therapeutic Effectiveness
Masks Produced at 150 Million per Week
Typically 40 Million Sold, Supply Situation Favorable
Considered a 'Small Victory' in the War Against COVID-19
50% of Production Exportable... Transportation Is the Issue

Lee Eui-kyung, Commissioner of the Ministry of Food and Drug Safety. / Photo by Hyunmin Kim kimhyun81@

[Interview with Lee Jung-il, Deputy Director and Head of the 4th Industrial Department] The most certain weapon to end the novel coronavirus infection (COVID-19) crisis is therapeutics or vaccines. This is why the shoulders of regulatory authorities are heavy. Since pharmaceuticals require not only therapeutic efficacy but also ensured safety, they must be approached cautiously, like tapping a stone bridge. However, being overly cautious is not an option either. It is now a 'race against time.' Lee Ui-kyung, Commissioner of the Ministry of Food and Drug Safety (MFDS), said, "We have reduced the average clinical trial approval review period from one month to 5.7 days while meticulously examining the safety of drugs during clinical trials."

This means that in the unprecedented crisis situation called the 'war against COVID-19,' the focus is on finding an appropriate balance between 'safety' and 'therapeutic efficacy.' Regarding the 'mask shortage' experienced in the early stages of the COVID-19 crisis, he explained, "Currently, the supply and demand situation is stable, with 150 million masks produced weekly and 40 million consumed." During this process, MFDS staff stayed at mask production factories to support on-site operations. The stabilization of mask supply and demand, which was barely achieved, is regarded as a 'small victory' in the war against COVID-19. We recently met Commissioner Lee Ui-kyung at the Seoul Regional Food and Drug Safety Office.

-The previously chaotic mask supply and demand is stabilizing rapidly. How did this happen?

▲Until January and February, about 40 to 50 million masks were produced weekly, but now production has increased to 150 million masks. Typically, about 40 million masks are sold weekly. Since last month, we started supplying droplet-blocking masks, which now account for one-third of total production. The supply of droplet-blocking masks is also stable. Unlike before, the need to wear masks indoors for extended periods has increased, and new standards were created considering breathability and other factors to meet this demand. Some materials like filters were previously dependent on China, but through the COVID-19 crisis, domestic production has been established, strengthening the domestic mask production base. Currently, the government maintains a stockpile of 150 million masks, and with the expanded production base, rapid response is possible even if a resurgence or crisis occurs.

-The stabilization of mask supply is considered a 'small victory in the war against COVID-19.' Could you elaborate?

▲In the early stages of the COVID-19 crisis, two MFDS officials were assigned to each mask production company to ensure proper production and distribution and to support the companies' needs. At that time, there were about 130 companies, so 200 to 300 officials worked on-site. Filters are crucial for masks, and most domestic companies lacked some imported components. We later negotiated with related ministries to support the development of domestic filters, and now 'Korean masks' are recognized internationally for their high quality. K-Quarantine is gaining international recognition, and Korean-made masks contribute to this reputation.

-COVID-19 is still spreading overseas. How is the mask export situation?

▲Since the public mask system ended, up to 50% of production can be exported. Several companies are negotiating with overseas buyers as their quality is recognized. However, recent urgent situations require air transport, which is expensive and challenging. N95 masks used for surgery and medical purposes are classified as medical devices in many foreign countries, but in Korea, they are classified as quasi-drugs, making exports difficult. We are reviewing ways to align classifications internationally to resolve this issue.

Lee Eui-kyung, Commissioner of the Ministry of Food and Drug Safety. / Photo by Hyunmin Kim kimhyun81@

18 Domestic Approvals for Therapeutics and Vaccines
13 Currently Underway After Efficacy Evaluation
Additional Applications Under Review

-The development of COVID-19 therapeutics and vaccines is urgent. What are the key considerations in clinical trial plans?

▲Therapeutics mainly involve drug repurposing, using previously approved substances for different indications, so since safety is already verified, the focus is on efficacy. Vaccines, on the other hand, require long-term monitoring for side effects, but since many people must be vaccinated in a short period if developed, safety is prioritized. So far, 18 clinical trials have been approved, with 13 currently underway except for some that have been authorized or excluded. Additional applications are also under review.

-Since it is a 'race against time,' shouldn't clinical trials be expedited?

▲Before review, we provide guidelines and conduct consultations to help companies and research institutions reduce trial and error. We prioritize reviews and approvals for these products and assist with additional R&D or sourcing overseas supplies through relevant ministries. Previously, clinical trial review took about a month on average, but now it has been reduced to 5.7 days. Experienced staff handle reviews exclusively, speeding up administrative procedures overall.

-Following the US International Trade Commission (ITC) preliminary ruling, the 'verbal battle' between Medytox and Daewoong Pharmaceutical over botulinum toxin is intense. Any comments?

▲The full preliminary ruling has not been released yet, and the final judgment is pending, so I am cautious about commenting. However, the pharmaceutical industry deals with medicines and requires a high level of ethical standards. K-Quarantine and the K-Bio industry are just beginning to gain recognition, so trust must be established both domestically and internationally.

Food and Drug Regulations Are Directly Linked to Safety
Should Be Connected to Industry Promotion Rather Than Hindrance

-There are moves in the National Assembly to enhance MFDS's infectious disease response capabilities. Could you explain?

▲Although the names differ slightly, bills have been separately proposed since last month to ensure timely supply of 'public health emergency medical products.' The purpose is to establish legal grounds to use new drugs and medical devices more quickly during disasters like COVID-19. While the scope of application and special cases vary, the goal is the same: to allow MFDS to grant rapid approvals with post-market surveillance. Currently, there are procedures like emergency use authorization and special imports, but these are separate; the aim is to consolidate them into a legally binding framework.

-You emphasize promoting the pharmaceutical and bio industries. What role is important as a regulatory agency?

▲International trust that 'if Korea's MFDS approves it, it is safe and reliable' must be established so that domestic companies can operate more easily overseas. Regulations in food, pharmaceuticals, and medical devices are directly linked to safety, so they should be seen as minimum standards to guarantee quality rather than obstacles to the industry. Regulatory work and industry promotion are interconnected. Korea recently took the inaugural chairmanship of the international medical device regulatory forum's AI sector, highlighting the importance of building international networks. To lower barriers for foreign governments to adopt Korean medicines, MFDS must first raise trust by aligning reviews with international standards.

-Managing imported food safety must be challenging amid COVID-19. How is it handled?

▲We have shifted overseas manufacturing facility inspections to non-face-to-face (untact) inspections, where the counterpart government conducts hygiene checks and shares results. We have big data of 10 million import food inspections from about 190 countries, and we apply machine learning techniques to score the likelihood of non-compliance for random sample inspections. To prevent forgery and alteration of certificates, we are building an international electronic hygiene certificate exchange system using blockchain technology.

This content was produced with the assistance of AI translation services.