Regulatory Overhaul Aims to Expedite Market Access for Innovative Therapies
The Korea Ministry of Food and Drug Safety (올림푸스 슬롯사이트) is under the spotlight after Korea Lilly became the first company to submit a new drug application (NDA) under the country's newly reformed drug approval system. In response, the 올림푸스 슬롯사이트 has provided preliminary consultations and assembled a dedicated review team.
According to industry sources on February 5, Korea Lilly filed for market authorization of imlunestrant, a breast cancer therapy, marking the first NDA since the 올림푸스 슬롯사이트 overhauled its approval process and significantly increased approval fees.
As of January 1, the 올림푸스 슬롯사이트 has been implementing a reform plan aimed at enhancing efficiency, transparency, and expertise in drug approvals. To support this, the agency expanded its professional workforce and increased approval fees 50-fold to approximately 0,000. The reform also introduced a pre-registration system for supplementary materials and allowed companies to request explanatory meetings in advance.
The 올림푸스 슬롯사이트 aims to reduce the approval timeline from 410 days to 295 days by strengthening preliminary consultations and enabling discussions even before NDA submission. Korea Lilly utilized this system, conducting a pre-submission consultation, leading the 올림푸스 슬롯사이트 to form a dedicated review team for the application.
Imlunestrant, the drug in question, is an oral selective estrogen receptor degrader (SERD) for treating estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. In the Phase 3 "EMBER-3" trial, it showed statistically significant improvement in progression-free survival (PFS) compared to standard endocrine therapy.
Notably, for patients with estrogen receptor 1 (ESR1) mutations, imlunestrant reduced the risk of disease progression or death by 38% compared to conventional treatment. When combined with the CDK4/6 inhibitor Verzenio (abemaciclib), the therapy lowered the risk by 43% compared to monotherapy. The median PFS was 9.4 months for the combination group, compared to 5.5 months for imlunestrant alone and 3.8 months for endocrine therapy. These findings were published in theNew England Journal of Medicineand presented at the San Antonio Breast Cancer Symposium.
The industry is closely monitoring the NDA process. One expert noted, "The 올림푸스 슬롯사이트’s reform signals Korea’s regulatory framework evolving to global standards. If the new system shortens market entry for innovative therapies, patients will benefit from faster access to cutting-edge treatments."
Another industry source added, "A streamlined approval process will not only benefit global pharmaceutical companies but also encourage domestic biotech firms to invest more aggressively in drug development, strengthening the entire industry."