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  • KRPIA expresses concerns over drug approval fee hike
  • by Eo, Yun-Ho | translator Alice Kang | Sep 27, 2024 05:53am
KRPIA ¡°The sudden increase in new drug approval fee may increase industry burden¡±
¡°The fee hike should be accompanied by an overhaul of the new drug approval system and the introduction of fast and advanced administrative services.¡±
¡°The pharmaceutical industry is bound to feel burdened by the sudden decision. We hope that the new drug approval system will be adjusted through discussions with the industry.¡±

The Korean Research-based Pharmaceutical Industry Association (KRPIA) expressed the pharmaceutical industry's stance regarding the amendment to the 'Fee Regulations for Approval of Drugs, etc.' that was announced by the Ministry of Food and Drug Safety (MFDS) on the 9th.

As part of the ¡®Measure for Innovation in New Drug Approval', the MFDS is expected to dramatically increase the fee for new drug approval from KRW 8.83 million to KRW 410 million, which is a nearly a 50-fold increase, by fully applying the benefit principle.

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