Prescription drug approvals hit 3-year high in 1H 2026

499 prescription drugs approved in 1H…up 58% year on year

Monthly approvals exceeded 100 in April and June… companies accelerated new product development, including fixed-dose combinations

Industry seen rushing approvals ahead of August changes to generic pricing rules

The number of prescription drug approvals in Korea reached a three-year high in the first half of 2026, reflecting pharmaceutical companies' active efforts to expand their product portfolios and enter new markets. There are also some analyses that many companies accelerated regulatory filings to secure reimbursement at higher prices before generic pricing reforms take effect in August. Although approvals rebounded during the first half of this year, the total remains more than 70% lower than 6 years ago following tighter pricing and regulatory policies introduced since 2020.

According to the Ministry of Food and Drug Safety (MFDS), 499 prescription drugs were approved during the first half of 2026, representing a 58.4% increase from the same period last year. After reaching 585 approvals in the first half of 2023, the figure declined to 324 in 2024 and 315 in 2025 before rebounding this year to its highest level in 3 years.

The increase suggests pharmaceutical companies have recently stepped up efforts to expand their product portfolios. June alone accounted for 118 approvals, while 106 products were approved in April, marking the second month this year in which monthly approvals exceeded 100.

By comparison, only July recorded more than 100 prescription drug approvals last year. Also, no month exceeded that level in 2024. In 2023, only January surpassed the 100-approval mark.

Average monthly approvals reached 83 products during the first half, the highest level since the 93 recorded in 2022. Although the annual monthly average had declined from 93 in 2023 to 76 in 2024 and 48 in 2025, approvals have rebounded to an upward curve this year.

Among the products approved in June, 48 orally disintegrating tablet (ODT) fixed-dose combinations of ezetimibe and rosuvastatin received marketing authorization. Companies obtaining approvals included Theragen Etex, Il-Yang Pharm, Ilhwa, Celltrion Pharm, KS Pharm, Dongkook Pharmaceutical, Mother’s Pharmaceutical, Jin Yang Pharmaceutical, HanAll Biopharma, Daehan Nupharm, Unimed Pharm, Withus Pharmaceutical, GC Biopharma, CMG Pharmaceuticals, Samjin Pharmaceutical, and GL Pharma.

Competition also intensified in the market for potassium-competitive acid blockers (P-CABs) containing vonoprazan. Vonoprazan, the active ingredient of Takeda's product Vocinti that has not yet been launched in Korea, attracted significant interest, with Korean pharmaceutical companies obtaining 58 approvals for generic vonoprazan products during the first half alone. Companies preparing to enter the vonoprazan market include CMG Pharmaceutical, Unimed Pharmaceutical, Korea PMG Pharm, Medica Korea, DongKoo Bio & Pharma, Samjin Pharmaceutical, Eden Pharma, Celltrion Pharm, Alvogen Korea, BC World Pharmaceutical, KS Pharm, Yuhan Corporation, Dongkook Pharmaceutical, Genu Pharma, YooYoung Pharmaceutical, KyongDong Pharml, Vivozon Pharmaceutical, Hana Pharm, Korea Prime Pharm, GenuOne Sciences, Kolon Pharma, Korea Arlico Pharm, Ahn-Gook Pharm, Saehan Pharm, GC Biopharma, White Life Science, Samik Pharm, Mother’s Pharmaceutical, and Kyongbo Pharmaceutical.

Industry observers believe another factor behind the increase is companies' efforts to secure as many reimbursements before the pricing reform takes effect in August.

Under proposed revisions to the ‘Standards for the Determination and Adjustment of Drug Prices’ recently released by the Ministry of Health and Welfare (MOHW), the maximum reimbursement price for both off-patent originators and generic drugs will fall from 53.55% to 45% of the original branded drug price beginning in August, equivalent to a 16% reduction in generic reimbursement prices.

Price reductions could become even steeper for products that fail to satisfy the requirements for receiving the highest reimbursement level, including conducting their own bioequivalence studies and using domestically registered active pharmaceutical ingredients (APIs).

Under the revised system, the penalty for failing to satisfy the maximum-price requirements will increase from 15% to 20%. Since July 2020, generic manufacturers have been required to both conduct their own BE studies and use registered APIs to qualify for the maximum reimbursement price of 53.55%. Previously, the reimbursement ceiling fell by 15% for each unmet requirement, resulting in a total reduction of 27.75% if neither criterion was met. Under that system, reimbursement fell from 53.55% to 45.52% when one requirement was unmet and to 38.69% when neither requirement was satisfied.

Under the revised framework, the new maximum reimbursement ratio of 45% will fall to 36% if one requirement is not met (20% cut) and to 28.8% if neither requirement is satisfied. Compared with the current system, these changes represent additional reimbursement reductions of 20.9% and 25.6%, respectively.

From the industry's perspective, obtaining reimbursement before implementation of the new pricing rules allows products to receive relatively higher reimbursement prices, providing a strong incentive to accelerate approvals.

Despite this year's rebound, prescription drug approvals remain well below historical levels. During the first half of 2019 and 2020, the MFDS approved 2,209 and 2,015 prescription drugs, respectively. The total fell to 1,073 in the first half of 2021 before declining further from 2022 onward. Compared with 2020, approvals in the first half of 2026 were 75.2% lower.

Industry analysts attribute the sustained decline in generic market entry to changes in both the drug pricing and regulatory systems.

Beginning in July 2020, Korea introduced a tiered reimbursement pricing system, under which reimbursement ceilings decline the longer the listing is delayed. Once 20 or more generic products are listed for a given ingredient, newly listed products are reimbursed at only 85% of the lowest existing reimbursement price. Because companies that do not independently develop generics or conduct their own bioequivalence studies receive substantially lower reimbursement, approvals for fully consigned generics have declined sharply.

Regulatory barriers have also become more stringent. Since July 2021, amendments to the Pharmaceutical Affairs Act introduced the so-called "1+3 rule," limiting the number of generic and incrementally modified drugs that can rely on a single bioequivalence study.

Under the regulation, if a generic is manufactured at the same facility using the same formulation and manufacturing process as the product for which the bioequivalence study was conducted, the bioequivalence data may be referenced by only three additional products. In other words, one bioequivalence study can support approval of only four generic products. Likewise, clinical data may be shared only with the original contract research organization’s product and up to three additional products.

Previously, once one manufacturer obtained approval based on a bioequivalence study, dozens of other companies frequently obtained approvals for outsourced generics using the same data. The introduction of restrictions on joint development effectively ended the practice of unlimited generic replication.

The surge in approvals during 2019 and 2020 was itself driven by anticipation of tighter government regulation. In 2018, sales of 175 valsartan-containing antihypertensive products were suspended after excessive levels of impurities were detected. In response, the MOHW and MFDS established a consultative body to develop measures aimed at curbing the excessive proliferation of generic drugs.

As the government signaled stricter regulation, pharmaceutical companies rushed to secure generic approvals before the new rules took effect. Since implementation of the reforms, however, new market entry has slowed considerably.