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  • MFDS clarifies support for advanced biopharmaceuticals
  • by Lee, Hye-Kyung | translator Alice Kang | Aug 4, 2025 05:53am
Clarifies standards on fee reductions and support measures for advanced biopharmaceuticals
MFDS announces revision of ¡°Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products¡±
With the Ministry of Food and Drug Safety raising the approval and review fees for advanced biopharmaceuticals by up to KRW 410 million from January 1 this year, it has clarified the criteria for those eligible for fee reductions.

In addition, detailed administrative disposition standards have been set for cases where human cell managers and cell processing facilities commit two or more violations.


According to industry sources on the 1st, the MFDS recently re-announced its partial amendment to the Regulations on the Safety and Support of Regenerative Medicine and Advanced Biological Products and is collecting opinions.

The revision includes the following provisions: ¡ãIntegration of forms related to new dr
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