Kim Kang-lip: "Rekkirona Domestic Approval → EMA Approval, Our Review Recognized Internationally"

Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety, is speaking at a press conference held on the 17th at the MFDS in Osong, Chungbuk. (Photo by Ministry of Food and Drug Safety)

[Asia Economy Reporter Lee Chun-hee] Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety (MFDS), said regarding the approval of Celltrion's COVID-19 antibody treatment 'Rekkirona,' which was first approved worldwide by the MFDS and has now been approved by the European Medicines Agency (EMA), "It seems that our review has received a kind of international recognition," adding, "This will remain a great source of pride for me and the staff."

At a press briefing held on the afternoon of the 17th at the MFDS in Osong, Chungbuk, Commissioner Kim stated, "Facing the national and global health crisis of COVID-19, the MFDS has taken a path not previously traveled," and added, "Completing the approval process for a domestic treatment in just 40 days was a tremendous challenge."

Commissioner Kim also shared, "We completed the approval in 40 days, but as the EMA approval took a long time and if a different decision had been made, fundamental doubts about the MFDS's regulatory capabilities would have inevitably arisen, so we were very anxious," and recalled, "When the EMA approved the treatment with an even broader indication than ours, I sent a message to the staff in charge of the approval work saying, 'Even though we reviewed it for 40 days, we did so as thoroughly as those who reviewed it for 9 months.'"

Celltrion COVID-19 Antibody Treatment 'Rekkirona' (Photo by Celltrion)

Regarding vaccine introduction, he emphasized, "Although it seems easy to approve vaccines already authorized in other countries, reviewing documents exceeding 10,000 pages was by no means easy," and added, "Internally, we take pride in having completed this process smoothly with our staff." He also mentioned that in processes such as shipment approval, "There were times when the usual 2 to 3 months required was shortened to 20 days or even less."

Commissioner Kim also expressed the difficulties encountered during these processes. He said, "What was regrettable was that when unfavorable results came out during clinical trial approvals or conditional product approvals, or when indications were reduced for approval, the departments were overwhelmed with phone calls and could not work for days," and added, "We realized how intense the interest of our country's stakeholders is, as they even requested information that could not be disclosed."

He further explained, "The U.S. Food and Drug Administration (FDA) and EMA have never disclosed the personal information of reviewers as we do," and noted, "This was the background for switching to a department representative phone system."

Regarding recent concerns raised overseas about poor management of clinical trials for COVID-19 vaccines such as Pfizer's, he stated, "While additional verification is needed, we do not believe the issue with a specific company is enough to question the overall reliability of vaccine clinical trials," and added, "It is difficult to make a clear statement based on the information available so far."

He also noted, "We are considering the fact that the cases handled by the company in question are only about 1,000," and added, "The FDA has said further verification is necessary, and Pfizer has stated that there is no significant flaw in data integrity."

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