Why does Korea's bio approval system still rely on temporary task force?

Despite the rapid growth of Korea’s biopharmaceutical market, the government's approval system to support it still relies on a temporary organization.

The Biopharmaceutical Approval Task Force, operated by the Ministry of Food and Drug Safety (MFDS), has been maintained as a temporary organization without a permanent position, raising concerns that continuity and expertise in biopharmaceutical regulation are difficult to secure.

Although the new government emphasizes its policy of fostering bio as a strategic industry for the future, there are concerns that the current situation without a dedicated department in charge of biopharmaceutical approval may damage the credibility of the policy.

The only ‘ad hoc system’ for bio approval in contrast to synthetic drugs and medical devices

The MFDS’ Biopharmaceutical Approval Task Force, which is in charge of biopharmaceutical approval, was established in 2023 as a temporary organization under the Biopharmaceutical Policy Division within the Biopharmaceutical Bureau, as the existing General Approval Officer and Advanced Product Approval Officer were abolished.

At the same time, synthetic drugs were reorganized into the Pharmaceutical Approval Management Division and medical devices into the Medical Device Approval Division. While the two divisions officially belong to the Pharmaceutical Safety Bureau and the Medical Device Safety Bureau, the Bio Approval TF remains an irregular task force

The Biopharmaceutical Approval TF has seven members, compared to 17 people in the Pharmaceutical Approval Management Division, which performs the same functions. The TF organization oversees all aspects of biopharmaceutical approval, including new drug approval, notification, guideline formulation, and quality assessment. Still, the organization and manpower are significantly limited compared to regular positions.

Biopharmaceutical approvals are increasing every year, making it difficult to respond to crises without a 'supervising function'

According to the MFDS, the number of biopharmaceutical approvals in Korea has increased yearly, from 52 in 2021 to 53 in 2022 and 59 in 2023. The share of biopharmaceuticals in new drug approvals is also gradually expanding. From 2020 to 2024, around 10 new biopharmaceutical drugs were approved annually, and the proportion of all new drugs is also increasing.

Within the MFDS, there are growing calls for the Bio Approval TF to become a full-time position and function as an “approval control tower.”

As the bio market is growing rapidly, we need a regular organization to oversee the approval of biopharmaceuticals,” a ministry official said, pointing out that while there are formal control towers in bureaus for synthetic drugs and medical devices, there is no such organization for biopharmaceuticals.

“The organization remains ad hoc while performing major tasks, such as establishing approval guidelines and revising test method notifications, making it difficult to ensure the permanence of regulations,” the official noted. He added that this organizational vacuum could become even more pronounced ahead of 2025 when the new drug approval innovation policy is scheduled.

Biopharmaceuticals should also have an ‘overseeing department’

Another MFDS said, “The licensing department must be able to respond to various medical product licensing issues in a coordinated manner. For this reason, the Pharmaceutical Approval Management Division and the Medical Device Approval Division have been shaped into regular organizations. Still, the bio sector remains in the TF due to insufficient manpower.”

“There may be more chemical drugs and medical devices than bio in the number of approvals, but bio is by no means inferior in terms of medical and technological importance,” he said. “The Bio Approval TF must be regularized to be a proper approval control tower.”

The bioindustry is also calling for formalizing the Bio Approval TF, pointing out that a lack of clarity as a communication channel can lead to confusion when responding to complaints and applying for approval. Industry insiders commonly say it is difficult to find the correct department or person in charge when discussing approval issues with MFDS.

The organizational chart on the MFDS’ website reflects this reality. While the Pharmaceutical Approval Management Division and Medical Device Approval Division are clearly labeled, one must search further under Biopharmaceuticals and Herbal Medicine Bureau to find the department in charge of biopharmaceutical approval. As a result, the bioindustry is losing predictability and administrative efficiency in the approval process.

'Reorganization' discussion urgently needed ahead of new drug innovation policy

The MFDS plans to implement a new drug approval innovation plan starting in 2025. The plan aims to shorten the approval period from the current average of 420 days to 295 days. The plan includes a complete overhaul of the approval system, including establishing a dedicated team for every new drug application, expanding pre-approval consultations with companies, and holding more briefings and pre-review meetings.

However, insiders say that for such an innovation policy to work successfully, it requires a formalized organization and sufficient manpower. Biopharmaceuticals require rapid and specialized responses due to their high-tech, high-cost development, and rapid market volatility.

Biopharmaceuticals are often used to treat rare diseases, anticancer drugs, and others with high medical demand, and the approval process is complex. In many cases, the relevant regulations and standards have not yet been fully established, so there is a greater need for a centralized control organization to establish standards in advance and ensure consistency in review.

Government emphasizes bio policy but there is a 'hole' in approval process

The government has called the bio-health industry the “food industry of the future” and offers various support measures. The national bioeconomy vision has been announced several times, and each ministry supports R&D. However, the regulatory framework to support the industry, especially the administrative infrastructure related to licensing, remains “ad hoc.”

Bio-venture firms consider regulatory compliance from the earliest stages of R&D to formulate clinical and licensing strategies, and clear and consistent regulatory channels play a crucial role in this process. Therefore, formalizing the department in charge of licensing is not just an administrative adjustment but a key factor in the industry's competitiveness.

With growing demands from the bioindustry and within the MFDS, experts stress that it is time for the government to answer the question: Why is the fate of the future industry still in the hands of an ad hoc organization?