[Reporter's View] Divisional restructuring needed

for the bio approval system

During his candidacy, President Lee Jae-myung pledged to designate the biotech industry as a cutting-edge sector and build it as the future growth engine, aiming to position South Korea as one of the world's five strongest biotech countries.

 

Based on an analysis that the previous government was short on investment in the pharmaceutical and biotech industry, President Lee will likely plan to implement policies geared at establishing special funds and fostering talents with expertise to strengthen national investment and responsibility in the pharmaceutical and biotech industry.

 

Firstly, there will be expanded support at the R&D center, focusing on venture technologies.

 

To achieve this, regulatory support is crucial.

 

To set a goal of becoming a strong biotech country, aggressive R&D must be pursued.

 

Additionally, supporting measures for venture firms with less regulatory experience are also necessary.

 

Celltrion, for instance, which successfully overtook the No.

 

1 place in exporting biopharmaceuticals in South Korea, was established in 2002 as a biotech venture company.

 

Therefore, when aggressive R&D takes place, there will be more venture firms with fewer years of regulatory experience that will robustly grow.

 

The problem lies in whether the Ministry of Food and Drug Safety (MFDS), which is responsible for providing regulatory support to make South Korea one of the top five global biotech powerhouses, can properly fulfill its role.

 

In particular, the division responsible for pharmaceutical approvals is operating as a temporary task force (TF), with a fixed staff of only seven people managing all approval-related tasks for biopharmaceuticals, Korean traditional medicines (han-yak), and quasi-drugs.

 

Although the current government has promised active investment in biotech, it remains uncertain to determine how much will be allocated for pre-registration or applications for new drug approval.

 

Furthermore, the government implemented an innovative measure to shorten the new drug approval duration from 420 to 295 days this year, which also includes biopharmaceuticals.

 

According to the number of approved new drugs by year, the number of chemical medicines decreased from 29 in 2023 to 11 in 2024.

 

In contrast, the number of biopharmaceuticals increased during the same period, from 8 to 12 cases.

 

For biopharmaceuticals, which are often high-priced, cutting-edge therapies for rare·intractable diseases or cancers with significant medical demand, the approval process is complex.

 

If the approval division isn't functioning properly, it becomes challenging to ensure swift internal and external communication or make highly reliable decisions based on scientific·legal reviews.

 

Related to this, it's puzzling why the Pharmaceutical Approval Management Division remains a task force (TF).

 

This bio approval TF was established in May 2024 when the Vice Minister's direct reporting divisions for overall approval management and advanced product approval were reorganized and redistributed across three bureaus: Pharmaceutical Safety Bureau, Biopharmaceuticals and Herbal Medicines Bureau, and Medical Device Safety Bureau, to strengthen the linkage between medical product approvals and policy.

 

While this reorganization converted two existing divisions into three, resulting in 'Approval Divisions' for pharmaceuticals and medical devices, only bio approvals were structured as a "team"-based TF.

 

Reportedly, MFDS faced limitations in creating new official divisions under its organizational regulations, leading to the establishment of permanent divisions for pharmaceuticals and medical devices, which handle a relatively higher volume of public complaints and regulatory support).

 

Yet, it's difficult to comprehend.

 

At the same time, the bio-related function was set up as a temporary task force.

 

This is particularly difficult to understand given that becoming a biotech powerhouse has been a national priority since the previous administration, and it's a commitment significant enough to be a presidential pledge in the current government.

 

The Pharmaceutical Approval Management Division serves as the manager for the entire approval process and acts as a communication channel between external stakeholders and the MFDS.

 

Operating as a temporary organization with only seven full-time staff means that even the absence of a single employee can jeopardize the swift processing of applications and approvals.

 

If the approval department doesn't function properly, it becomes difficult to ensure quick internal and external communication or make reliable decisions based on scientific and legal reviews.

 

While the current proportion of pharmaceuticals in the overall medical product industry in South Korea may still be low, there's significant potential for further growth, depending on the role of the President Lee government.

 

To accelerate the commercialization of domestically developed biopharmaceuticals and secure a leading global position, the MFDS will likely need to reorganize its structure to provide proactive regulatory support.