Health · Healthcare & Policy · 2 hrs ago
South Korea plans higher approval fees for advanced medicines
South Korea’s food and drug regulator proposed raising medicine approval fees in a draft rule change announced on November 6.
Fees for advanced biological medicines and new biological medicines would each rise from 8.03 million won to 20.71 million won.
Fees for medicines that are not new drugs but still need safety and effectiveness reviews would rise from 2.6 million won to 16.04 million won.
Advanced biological medicines include cell and gene therapies, which require detailed quality and safety checks.
The regulator says the higher charges would help support more staff for complex reviews.
It expects this to improve the quality of approval and review services.
The changes were proposed for public notice, and the source does not say when they might take effect.
South Korea plans to raise approval fees for advanced biopharmaceuticals and new biological medicines from 8.03 million won to 20.71 million won.
The Ministry of Food and Drug Safety announced proposed amendments to fee rules on November 6.
Fees for medicines requiring data submission would rise from 2.6 million won to 16.04 million won.
The ministry said the changes aim to bring fees for complex reviews closer to their costs and support more review staff.
- Who
- South Korea’s Ministry of Food and Drug Safety.
- What
- It proposed higher approval fees for advanced biopharmaceuticals, new biological medicines and medicines requiring data submission.
- When
- November 6, 2026.
- Where
- South Korea.
- Why
- The ministry said the fees needed to reflect the costs of complex reviews and help expand approval and review staffing.
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- Advanced biopharmaceuticals and new biological medicines
- Approval fee proposed to rise from 8.03 million won to 20.71 million won
- Medicines requiring data submission
- Fee proposed to rise from 2.6 million won to 16.04 million won
- Proposal announced
- November 6, 2026
- Ministry
- Ministry of Food and Drug Safety
1 source
What people are saying
We expect that bringing fees closer to actual costs will create a basis for expanding approval and review staff and help ensure the quality of approval and review services for medicines requiring complex reviews.