MedPath

South Korea's MFDS to Increase New Drug Approval Fees to Expedite Review Process

• The Ministry of Food and Drug Safety (MFDS) in South Korea will raise new drug approval fees from 8.83 million won to 410 million won starting January 1 next year. • MFDS aims to shorten the review period for new drugs by ensuring GMP due diligence is conducted within 90 days of receiving applications. • The increased revenue will fund the expansion of review personnel by over 100 and enhance their training and infrastructure. • The ministry plans to improve consultation processes and increase face-to-face contact to enhance the predictability of the approval process.

The South Korean Ministry of Food and Drug Safety (MFDS) has announced a significant increase in new drug approval fees, set to take effect on January 1 of the coming year. This decision, made after consultations with fiscal authorities, aims to expedite the drug review process and enhance the predictability of approval timelines for pharmaceutical companies.
The new fee structure will raise the cost of licensing a new drug from 8.83 million won ($6,300) to 410 million won. While the pharmaceutical industry has expressed concerns about the steep increase, the MFDS maintains that the change is necessary to improve its review capabilities and infrastructure.

Streamlining the Approval Process

According to MFDS officials, the increased fees will enable the ministry to conduct Good Manufacturing Practice (GMP) surveys within 90 days of application receipt and GCP surveys within 60 days of the first supplement. This expedited due diligence is expected to shorten the overall review period for new drugs.
"We will improve the consultation process to increase face-to-face contact," said Kim Young-joo, director of the General Approval Division. "We will increase the predictability of (approval) for complainants and shorten the review period for new drugs by ensuring that GMP (Good Manufacturing Practice) due diligence is conducted within 90 days of receiving applications."

Investing in Review Capacity

The additional revenue generated from the fee increase is earmarked for expanding the MFDS's review personnel by more than 100. The ministry also plans to invest in training programs to enhance the expertise of its reviewers.
"If we estimate the number of new drug license applications to be 26-30 per year, about 10 billion won will be secured (from the fee increase). Accordingly, we plan to expand the number of review personnel by more than 100," said Director Kim Choon-rae of the Drug Policy Division.

Addressing Industry Concerns

While acknowledging the industry's concerns, the MFDS has indicated a willingness to review specific issues, such as potentially exempting new drugs with multiple contents besides main ingredients from additional fees and excluding new drugs for rare diseases from the approval fee. The ministry has stated that the increase will shorten the review period by 120 days, helping drug developers better understand the implications and benefits.
"We collected opinions from the pharmaceutical industry until last week," said Director Kim Choon-rae. "We have finalized the timing and process of the new drug approval fee increase, but we will adjust the details gradually."
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Finalized Diversity in Clinical Trials Guidance and Revised Short Form Consent Policy Implemented

The University of Washington has announced the finalization of the Diversity in Clinical Trials Guidance and the implementation of a Revised Short Form Consent Policy, effective from January 1, 2026. These changes aim to improve participation from underrepresented communities in clinical trials and streamline the consent process for non-English speaking participants.

FDA Clarifies Confirmatory Trial Requirements for Accelerated Drug Approvals

The FDA issued draft guidance clarifying requirements for confirmatory trials needed to verify clinical benefit of drugs receiving accelerated approval.
The guidance emphasizes early consultation with the FDA on trial design and the need for sponsors to commit sufficient resources for timely trial completion.

Elevar Therapeutics Addresses Regulatory Trends and Rivoceranib/Camrelizumab Review

Elevar Therapeutics highlights the FDA's evolving regulations, including accelerated approval pathways and Project Optimus, which focuses on optimizing drug dosage.
The company's COO, Seong H. Jang, emphasized that regulatory guidelines are continuously updated to keep pace with scientific advancements.

Novocure's Optune Device Receives Expanded FDA Approval for Lung Cancer Treatment

The FDA has expanded the approval of Novocure’s Optune device for metastatic non-small cell lung cancer after initial chemotherapy failure.
The approval was based on the Phase 3 LUNAR trial, which demonstrated a 3.3-month increase in median overall survival with Optune.

Novo Nordisk Faces Senate Scrutiny Over Ozempic and Wegovy Pricing

Novo Nordisk CEO Lars Fruergaard Jørgensen testified before the Senate regarding the high prices of Ozempic and Wegovy in the U.S.
A federal appeals court revived PhRMA's challenge to the Inflation Reduction Act (IRA), which will impact drug price negotiations.

Sarepta's DMD Gene Therapy Approval Faces Scrutiny Over Efficacy and Pricing

An article in JAMA questions the FDA's accelerated approval of Sarepta's Elevidys for Duchenne muscular dystrophy (DMD) due to efficacy concerns.
Elevidys, priced at $3.1 million per dose, failed to meet its primary endpoint in Phase I and Phase III EMBARK studies, raising cost-effectiveness questions.

FDA Rejects Regeneron's Accelerated Approval Applications Due to Lack of Confirmatory Studies

The FDA has rejected two accelerated approval applications from Regeneron Pharmaceuticals due to the absence of ongoing confirmatory studies.
This decision signals the FDA's intent to utilize its enhanced authority, granted in 2022, to ensure timely validation of drug efficacy.

FDA Intensifies Scrutiny on Accelerated Approvals for Cancer Drugs, Mandating Earlier Confirmatory Trials

The FDA is increasing its requirements for accelerated approvals of cancer drugs, emphasizing the need for companies to have comprehensive confirmatory trial plans upfront.
The Oncology Center of Excellence now wants to see confirmatory trials underway when companies submit applications for accelerated approvals, potentially impacting smaller biotechs.

FDA Draft Guidance Clarifies Requirements for Confirmatory Trials Under Accelerated Approval

The FDA has issued draft guidance on accelerated approval, focusing on when confirmatory trials must be 'underway'.
This guidance interprets 'underway' and details factors the FDA will consider before granting accelerated approval.

Reference News

[1]
Regulator defends new drug approval fee hike, plans faster review process - KBR
koreabiomed.com · Nov 13, 2024

MFDS dismisses industry demands for a grace period on new drug approval fee increase, set to rise from 8.83 million won ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy