Korea's Drug Agency Discusses Clinical Trial Approval Reforms with Industry

The Korea Food and Drug Administration (KFDA) is set to collaborate with the pharmaceutical industry to revise the clinical trial approval and review system. Recently, South Korea's pharmaceutical and biotech sector has been recognized as the 'second innovation engine' in Asia, following China. However, a decline in clinical trials and a slowdown in new drug approvals have been identified as weaknesses, prompting the government to accelerate discussions on regulatory improvements.

On June 5, the KFDA held a meeting titled 'Regulatory Innovation for Clinical Trial Approval' to address industry concerns and discuss necessary reforms. This meeting aimed to establish a foundation for rapid clinical approvals in response to the changing global clinical trial landscape and to enhance the competitiveness of the approval and review process.

The KFDA plans to review the policy recommendations and discussions from the meeting to incorporate them into future regulatory improvements and policy operations.

Shin Jun-soo, Director of the KFDA's Drug Safety Bureau, stated, "We will continuously listen to voices from the field and rationally improve regulations to ensure a balance between securing clinical trial safety and accelerating development, while maintaining communication with the industry."

The KFDA has been discussing improvements to the clinical trial system since last year, resulting in the creation of a supplementary casebook for clinical trial plan approvals and criteria for selecting participants in early-stage cancer clinical trials.

Meanwhile, ING Research, the economic and financial market analysis arm of the global financial group ING, recently published a report titled 'Korea: The Second Innovation Engine in Asia,' in which it described South Korea as "one of the most trusted countries for biopharmaceutical innovation in Asia."

However, ING Research pointed out that for the growth of South Korea's biopharmaceutical industry to continue, improvements in clinical trials and the regulatory environment are essential. According to the report, the number of ongoing domestic clinical trials decreased from 2,307 in 2024 to 2,175 last year. The number of new drug approvals also fell by 38% from 23 in 2024 compared to the previous year.

ING Research emphasized that reforms in drug pricing systems, expedited approval processes, clear patent protections, and improvements in insurance coverage will determine whether Korea can advance as a global leader in innovative drug development.