Parliamentary inspection of the MFDS to highlight

increasing the number of reviewers for domestically developed new drugs

President Lee Jae Myung accepts the requests from MFDS Minister Yu-Kyoung Oh and the biopharma industry

The Health and Welfare Committee is expected to focus on expanding expert reviewers, such as pharmacists·physicians, necessity, and budget

President Lee Jae Myung

During the upcoming parliamentary inspection of the Ministry of Food and Drug Safety (MFDS), the National Assembly is expected to highlight the need to increase the number of reviewers and support the formation of dedicated teams to provide customized approval services, all aimed at shortening the review period for domestically developed new drugs.

 

This move follows President Lee Jae Myung's directive to increase the number of drug reviewers by 300 to foster the K-Bio industry.

 

On October 20, both ruling and opposition members of the National Assembly's Health and Welfare Committee are focusing on the issue of increasing and expanding the new drug approval review staff, which is deemed necessary for developing the domestic pharmaceutical and bio-industry, during the MFDS parliamentary inspection scheduled for October 21.

 

President Lee Jae Myung ordered the expansion of the new drug review workforce, including biopharmaceuticals, during the 2nd Core Regulation Rationalization Strategy Meeting held at the Presidential Office in Yongsan, Seoul, on October 16.

 

President Lee specifically emphasized the increase in MFDS review staff, stating, "The Ministry of the Interior and Safety may object, asking why we are increasing the number of public officials, but let's disregard that and proceed." This was a response to MFDS Minister Yu-Kyoung Oh's previous announcement to significantly expand the review workforce and strengthen existing review services, including prior consultation, face-to-face consultation, and supplementary meetings, to transform the MFDS into a regulatory service agency centered on demand, focusing on the pharmaceutical companies seeking new drug approvals.

 

Minister Oh requested an increase of 300 MFDS reviewers to accelerate the review process (targeting 240 days), a request which President Lee accepted.

 

Members from the Democratic Party of Korea and the People Power Party on the Health and Welfare Committee agree on the need to improve the review environment for rapid domestic new drug marketing authorization.

 

They are expected to pursue related questioning during the parliamentary inspection.

 

Rep.

 

Nam In-soon (Democratic Party) plans to highlight the necessity of increasing the hiring of not only pharmacists but also physicians for dedicated review roles, following President Lee and Minister Oh's push for expanded review staff.

 

The increase of 300 MFDS reviewers requires an annual labor cost of KRW 15 billion, and the plan is to cover this cost by increasing review service fees.

 

Members on the Health and Welfare Committee are expected to specifically question MFDS on its plan to secure the necessary funding by raising the review fees for both synthetic drugs and biopharmaceuticals.

 

A Health and Welfare Committee official said, "The MFDS review staff, at about 300 people, is much smaller compared to the U.S.

 

FDA's approximately 9,000 staff and the European EMA's approximately 4,000 staff," and added, "Given the future blueprint of creating domestic global new drugs and fostering global pharmaceutical companies, we plan to question the need to foster new drug approval review team and the specific policy direction."