South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled an ambitious plan to expedite its drug review and approval process, as reported in a recent press briefing. The “New Drug Approval Innovation Plan” targets a significant reduction in the timeline for novel drug reviews to under 300 days, a stark contrast to the previous standard of 420 days. This initiative is part of a broader strategy to enhance Korea’s competitiveness in the global pharmaceutical market.
To accomplish this goal, the MFDS intends to form specialized review teams, each comprising 10-15 experts, including PhDs, medical doctors, and pharmacists with specific expertise in areas such as Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP). These teams will be responsible for handling each new drug application, with the aim of reducing the approval period by approximately 30%.
The MFDS also plans to increase interactions with pharmaceutical companies, boosting the number of meetings per filing from the current average of three to around ten. Manufacturing inspections at production sites will be conducted within 90 days of filing for approval. Additionally, the plan extends to medical devices, with the average approval time projected to be reduced to approximately 230 days from the current 300 days.
Funding for these enhancements will come from a substantial increase in filing fees for new drug applications. The fees will rise from the previous KRW 8.83 million (USD 6,591) to KRW 410 million (USD 306,061). This move aligns with international standards, comparing with fees charged by other regulatory bodies such as China’s National Medical Products Administration (NMPA) at RMB 593,900 (USD 83,400) for import drug filings, the US FDA at USD 4 million, Japan at around USD 320,000, and the EU at around USD 365,000. – Flcube.com
