MFDS' pharma policy keyword, 'shorten time'
By Lee, Hye-Kyung | translator Hong, Ji Yeon
25.01.21 05:30:29
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Higher fee for new drug approval…two pre-registration consultation sessions have been held
Will implement a 'Path Program' supporting the process from development to commercialization
According to the business plan announced by the Ministry of Food and Drug Safety (MFDS) this year, support policy to facilitate quick market entry for new drugs and innovative products stands out.
The 'Ministry of Food and Drug Safety's Major Policy Implementation Plan for 2025' announced on January 21 by the MFDS contains its aim to shorten the duration of development to commercialization using various systems.
First, the MFDS will newly establish a dedicated review team this year to provide expert consultation services at each approval stage.
▲Improvement of panel·process for approval·review.
The new drug approval fee increased to KRW 410 million. The MFDS will prioritize document review and GMP site monitoring a
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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