The Shift in Regulatory Strategy

The core of new drug approval is moving away from simply increasing the number of clinical phases and toward an approach that also considers the feasibility of patient recruitment and whether there is a lack of treatment alternatives. A representative example is Repliktu, which received full approval based on single-arm Phase 1/2 trial data, and is being viewed as a case in which, for rare patient groups, practical development feasibility and medical necessity were considered alongside standardized confirmatory trial requirements.

This trend is also connected to other development strategies. In Korea, attempts to improve development efficiency by incorporating interim results are increasing through methods such as adaptive 2b/3 trial designs, while in Japan, efforts are underway to promote both commercialization and evidence accumulation at the same time by combining conditional and time-limited approval with insurance coverage for regenerative medicine products.

Stronger Post-Approval Oversight Around Clinical Trial Reliability

There is also a growing recognition that clinical trials are not a process that ends once approval is obtained. In the National Assembly, a legal amendment was proposed to require confirmation of harm to participants even after the end of a clinical trial, making follow-up investigations mandatory at the 1-, 3-, and 5-year marks. Meanwhile, the courts imposed a heavy level of accountability by sentencing those involved in solicitation and data distortion during the approval process to four years in prison and a 40 million won fine.

Behind these changes is the judgment that as the bio industry grows, the side effects of speed-driven competition have grown as well. Going forward, innovation in clinical design alone will no longer be enough; it is becoming increasingly clear that companies must also prove how data were prepared and how post-trial harm is managed in order to gain the trust of both the market and regulators.

The Competitive Focus Shifts to Manufacturing and Quality Control

The center of competitiveness in new drugs is also rapidly shifting from the discovery of candidate materials to manufacturing and quality control. It was reported that CMC deficiencies account for 44% of the reasons for approval delays or rejections, and the government’s move to support a public CMC platform and specialized workforce training shows that domestic companies are most frequently running into obstacles at the stage of connecting research outcomes to actual approval and production.

The importance of quality control is being confirmed in the same way even outside pharmaceuticals, in the food sector. Kimchi starter culture technology has extended the quality maintenance period from the previous roughly 30 days to as much as 45 to 60 days, reducing the uncertainty of long-distance exports. This suggests that the value of technology is now determined less by the substance itself than by how consistently it can be produced and how long it can be maintained.

The Meaning of Data Standardization and Organizational Restructuring

In both clinical trials and medical practice, organizing data in an interpretable way is becoming more important than simply collecting it. Standardization research has begun based on about 300,000 cases of real-world cuffless blood pressure data, and at the clinical preparation stage, services have emerged that aim to reduce the CRO search and comparison process from eight weeks to around 10 days, showing how data-driven decision-making is changing execution speed.

However, as data and quality become central management issues, internal corporate authority structures are also being shaken up. Cases such as Hanmi Pharmaceutical’s Clinical Value Evaluation Team and the repositioning of quality functions as a risk management axis show a trend in which development and management are being tied into a single control system rather than remaining separate. At the same time, however, this is also increasing concerns about the expansion of management without sufficient expertise.