US and Japan ease new drug approval reviews

Amid intensifying global race for expedited reviews, gaps in system design and commercial incentives clear

China’s ‘overwhelming speed’ stands out… Korea’s fast-track system must go beyond shorter timelines to address commercial rewards

As the global biopharmaceutical market grows rapidly, competition among major countries' regulatory authorities over expedited drug reviews has intensified. As the success or failure of new drug development hinges critically on launch timing, nations are engaging in a ‘speed race’ by shortening review timelines and expanding conditional approvals. While Korea has also moved to streamline approval procedures, experts say additional measures are needed to improve the effectiveness and real-world impact of the system.

According to the 2025 Biopharmaceutical Industry Trends Report published by the Korea Biomedicine Industry Association(KoBIA) on the 30th, the global biopharmaceutical market has been growing at a double-digit annual rate and has become the central pillar of the pharmaceutical industry. In 2024, the global biopharmaceutical market reached USD 632.3 billion, representing an annual growth rate of 13.6%, and is projected to grow to USD 974.2 billion by 2028.

As the market expands, competition among regulatory authorities worldwide to accelerate their approval timeline has also intensified. Countries are strategically leveraging fast-track review and conditional approval pathways to expedite new drug launches and gain an edge in the global approval race.

The United States and Japan are currently at the forefront of expedited review frameworks.

First, the U.S. Food and Drug Administration (FDA) is establishing a multi-layered expedited review system, including ▲Fast Track, ▲Breakthrough Therapy, ▲Accelerated Approval, and ▲Priority Review.

The Fast Track designation applies to drugs intended to treat serious or life-threatening conditions that address unmet medical needs. Under this program, the FDA provides more frequent communication and guidance from the development stage and allows rolling submission and review of data, minimizing bottlenecks throughout development and review.

The Breakthrough Therapy designation is a more advanced program than Fast Track and is granted when a drug demonstrates or is expected to demonstrate a significant clinical improvement over existing treatments in early clinical trials. When this program is applied, the FDA assigns a multidisciplinary review team to provide intensive support across clinical, statistical, and manufacturing aspects, helping applicants to finalize development strategies at an early stage.

Accelerated Approval allows early authorization based on surrogate endpoints or interim clinical indicators, without waiting for final clinical results. However, post-marketing confirmatory trials are mandatory upon approval, and the FDA may modify or revoke approval if clinical benefit is not demonstrated in these trials. This clear delineation of post-approval responsibility alongside expedited review is central to the U.S. accelerated approval system.

Priority Review that shortens the review period itself after an application is submitted. It directly accelerates the launch timeline of new drugs compared to standard review. It applies to treatments for serious diseases or those expected to yield significant public health benefits.

Japan adopts a strategy that directly guarantees corporate profitability. The Pharmaceuticals and Medical Devices Agency (PMDA) supports early approval of innovative drugs primarily through Priority Review and the Sakigake program, while also fostering a regulatory environment that considers the potential for market success post-approval.

The Sakigake program is Japan's flagship fast-track review initiative for innovative new drugs for severe diseases that are expected to demonstrate superior clinical benefit over existing treatments. If a drug designated under Sakigake is the first in the world to apply for approval in Japan, the re-examination period can be extended up to 10 years. This effectively guarantees a long-term monopoly status equivalent to a patent, serving as a powerful incentive for global pharmaceutical companies to prioritize Japan as an initial launch market.

Rather than focusing solely on speed, Europe emphasizes regulatory differentiation based on the level of uncertainty. The European Medicines Agency (EMA) concurrently operates systems like Conditional Marketing Authorisation, Marketing Authorisation under Exceptional Circumstances, Accelerated Assessment, and the PRIority Medicines (PRIME) program, applying different approval pathways based on a drug's development stage and level of clinical evidence. The Marketing Authorisation under Exceptional Circumstances system acknowledges situations such as rare diseases where confirmatory trials may be impractical even after market entry, distinguishing Europe’s approach from other regions.

China is pursuing aggressive regulatory innovation centered on speed, accelerating its rise as a global biopharma powerhouse. The National Medical Products Administration (NMPA) operates multiple fast-track review systems, including Breakthrough Therapy Designation, Conditional Approval, Priority Review, and Special Approval.

Among these, the Special Approval system for public health emergencies is designed to initiate acceptance and initial review procedures within 24 hours, making it one of the fastest response systems globally. Priority review timelines have also been shortened significantly, from the standard 200 days to 130 days, reflecting China’s aggressive time-reduction strategy.

Korea has introduced expedited review and conditional approval systems in line with global regulatory trends. Through the GIFT (Global Innovative product on Fast Track) program, the Ministry of Food and Drug Safety (MFDS) shortens review timelines for innovative drugs and treatments for serious or rare diseases, while allowing conditional approval before full clinical evidence is accumulated.

Under GIFT, the review period is reduced by approximately 25%, from 120 days to 90 days. Additionally, the system has institutionalized rolling review, where approval data is submitted and reviewed in stages, to enhance review efficiency.

However, critics argue that Korea’s system still lags behind major countries in practical implementation. To achieve genuine global competitiveness, Korea’s GIFT program may require bold enhancements on par with those in leading jurisdictions. Just as Japan’s Sakigake program offers strong exclusivity incentives for first-in-world applications, Korea also needs to strengthen commercial incentives for companies by guaranteeing exclusivity for a certain period after approval or implementing exceptional drug pricing preferential policies.

Expanding the scientific flexibility of regulations and strengthening the expertise and authority of regulatory agencies are also identified as key tasks to enhance the competitiveness of the GIFT system. In areas with urgent unmet medical needs, such as cancer and rare diseases, there is an argument for more active acceptance of surrogate endpoints while shifting the regulatory paradigm toward strengthened post-marketing surveillance and post-approval verification. Analysis also suggests that strengthening the MFDS's bio-specialist workforce and institutionally guaranteeing the discretion and responsibility of reviewers must precede such changes.

An industry official commented, “We are now in an era where the quality of regulation directly determines a country’s biopharmaceutical competitiveness. Beyond simply accelerating approval timelines, the GIFT system's effectiveness will only truly increase when a clear commercial reward structure is established that allows for the recovery of the massive R&D costs invested in new drug development.”