In the past year, Korea has launched an ambitious suite of pharmaceutical regulatory reforms designed to accelerate drug approvals, foster innovation, and improve patient access to essential medicines. As the Ministry of Food and Drug Safety (MFDS) faces criticism over protracted review timelines, the Korean government has taken bold steps to modernize its processes and harmonize its systems with international benchmarks.

These efforts reflect a broader push to foster a more innovation-friendly regulatory environment while maintaining strong public health safeguards. From drastically reducing review timelines to expanding support for breakthrough products and regenerative medicine, Korea is signaling a new era in drug regulation.

Shortening Review Times Through Drastic Fee Restructuring

One of the most headline-grabbing moves has been Korea’s decision to reduce its average drug review time from 420 days to approximately 295 days. To accomplish this, the MFDS plans to significantly expand its review capacity by recruiting more highly qualified experts, including clinicians, pharmacists, and researchers with substantial postdoctoral experience. The proportion of these specialized reviewers is expected to more than double, from 30% to 70%.

To fund these upgrades, the MFDS has implemented a sweeping increase in application fees. Previously set at around 8.8 million won (USD $6,500), drug registration fees have now surged to 410 million won (USD $306,000), bringing them in line with rates seen in other ICH-member countries. Recognizing the burden this could place on smaller pharmaceutical developers, especially those advancing innovative therapies, a tiered fee structure has been introduced: early-stage or small-scale biopharmaceutical firms will pay just half the standard rate, and additional approvals from the same sponsor will cost only 10% of the base fee.

Moreover, dedicated review teams comprising 10 to 15 specialists will be assigned to evaluate each new drug application, ensuring focused and coordinated review processes. In parallel, inspection timelines for domestic manufacturing sites will be shortened to 90 days, reducing another major bottleneck in the approval process. Similarly, review durations for new medical devices are also being reduced from 300 days to 235.

New Regulatory Structure Rolled Out in 2025

Building on this momentum, the MFDS rolled out a new regulatory structure starting January 1, 2025. The goal: streamline drug approvals while improving communication and transparency with industry stakeholders.

The new framework offers several key enhancements:

Product-specific review teams will handle each submission for greater continuity and speed.
Drug developers are now permitted up to ten rounds of official consultation with MFDS, a significant increase from the previous limit of three.
Written summaries of all meetings and exchanges between reviewers and companies are now required to ensure accountability.
Evaluations of production facilities will be completed within 90 days from the submission of an application.

The MFDS has also streamlined the Korean Good Manufacturing Practice (GMP) certification system. Instead of submitting 11 document types, companies now need to submit only four key categories of documents. Furthermore, factories without substantial changes may extend their GMP licenses by up to two additional years through written correspondence with the MFDS, bypassing the need for an on-site inspection every three years.

Regenerative Medicine Law Ushers in New Era of Treatment Access

On February 21, 2025, Korea implemented a major legislative development with the introduction of a new law on regenerative medicine and advanced biological products. This initiative is designed to offer new treatment pathways for patients suffering from serious, rare, or untreatable conditions.

The law, formally titled the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, creates a regulated channel for access to therapies involving cells and genes that are not yet commercially approved but have demonstrated safety and efficacy in clinical studies.

Only 112 medical institutions across the country that specialize in regenerative treatments are authorized to administer these therapies. A national committee of up to 21 independent experts will oversee and evaluate each case to ensure scientific and ethical integrity.

To safeguard patients, the law mandates strict quality control, long-term monitoring of patient outcomes, and clear policies to manage potential conflicts of interest. Importantly, these therapies will not be covered by public health insurance, meaning that patients will need to pay out-of-pocket.

Unlike similar frameworks in the United States or Europe, Korea’s version does not apply to treatments using minimally processed human cells, such as umbilical cord blood. The approach is more centralized than Japan’s system and reflects a stricter regulatory posture.

Supporting Early-Stage Innovation Through Government Programs

The MFDS is also investing heavily in programs that guide developers of innovative products through the regulatory process. In March 2025, it introduced the GILJABI program – short for Guiding Insight to Lead the Journey toward Advanced and Breakthrough Innovative Products. This system is designed to assist early-stage innovators by offering targeted support during development, from initial design to final regulatory approval.

Starting in June 2025, twenty high-potential products will be selected to receive personalized guidance under the GILJABI initiative. Meanwhile, the GIFT program, launched in 2021, continues to support promising new therapies through an accelerated regulatory pathway.

To promote transparency, the MFDS is publishing detailed profiles of products in the GIFT program, including their mechanisms of action, available clinical trial data, and known safety concerns. In addition, a new public consultation forum, the HOPE Forum, will be established in 2025 to allow patients, industry, and regulators to engage directly on topics such as rare disease treatment.

An important advancement is the integration of the GIFT program with Korea’s national health insurance review system. This enables real-time data sharing between regulatory and reimbursement bodies, which speeds up post-approval decisions. For instance, the pediatric cancer therapy Qarziba (dinutuximab beta) received reimbursement within six months of approval – down from the previous average of more than a year.

Drug Pricing Reform to Encourage Innovation and Secure Supply

In April 2025, Korea’s Ministry of Health and Welfare announced a significant update to its pharmaceutical pricing system under a plan called Measures to Improve Drug Pricing Systems to Reward Innovation and Strengthen Health Security. The reform introduces financial incentives for manufacturers of high-value and essential medicines, while also reducing supply vulnerabilities.

Under the new pricing rules, innovative drugs that demonstrate superior or equivalent therapeutic effects compared to existing treatments can secure premium pricing. These medicines can be priced either at the highest level among existing alternatives or at 1.8 times the weighted average price of comparable products, whichever is lower – even without a formal cost-effectiveness analysis.

To bolster domestic supply chains, the government will offer up to a 27% price premium for essential medicines that are manufactured using locally sourced ingredients.

Another major change is the expansion of the Risk Sharing Agreement (RSA) framework. Originally created in 2013 for cancer and rare disease treatments, the RSA allows patients to access high-cost therapies while manufacturers and the government share the financial burden. This agreement will now be extended to cover additional chronic and serious illnesses, giving more patients access to essential medications without overwhelming insurance systems.

Conclusion

Korea is implementing bold and far-reaching changes to its drug regulatory landscape. By cutting review timelines, raising staffing standards, streamlining GMP requirements, and enhancing pricing mechanisms, the country is positioning itself as a progressive and efficient environment for both innovation and patient care.

Though the higher fees have raised some concerns among smaller developers, the government has attempted to balance this by offering reduced rates and tailored support. With implementation underway throughout 2025, the success of these reforms will be closely watched – not only by the pharmaceutical industry but also by patient communities who stand to benefit from quicker and more equitable access to cutting-edge treatments.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.