- Policy
- MFDS 'Review time shortened after the GIFT introduction'
- by Lee, Hye-Kyung Apr 23, 2025 06:11am
- Following the introduction of the Global Innovative products on Fast Track (GIFT) for global innovative products by the Ministry of Food and Drug Safety (MFDS) last year, the time it takes to review pharmaceuticals for severe disease has shortened significantly from the average of 115 days to 62.9 days. Furthermore, the number of approved cas
- Policy
- ‘Govt will resolve the supply issue of rare disease drugs’
- by Lee, Jeong-Hwan Apr 23, 2025 06:10am
- A private-public policy consultative body will be established to discuss support measures for manufacturers and sellers of rare disease drugs, medical devices, and special foods. The Korea Disease Control and Prevention Agency announced that a partial amendment to the Enforcement Decree of the Rare Disease Management Act, which provides t
- Policy
- MFDS turns down Jeffty’s integrated Phase II/III trial
- by Lee, Hye-Kyung Apr 22, 2025 05:59am
- The Ministry of Food and Drug Safety has rejected the clinical trial protocol for Hyundai Bioscience's COVID-19 drug Jeffty that the company submitted last year. According to the minutes of the MFDS's Central Pharmaceutical Affairs Council meeting that was released on the 17th, the council agreed that the integrated Phase II/III clinical
- Policy
- Boryung's follow-on drug referencing 'Lenvima' to be reimb
- by Lee, Tak-Sun Apr 22, 2025 05:59am
- The first follow-on medicines developed by Boryung similar to Lenvima (lenvatinib mesylate) is expected to be added to the reimbursement listing in May. This drug is made by addition of the new dimethyl sulfoxide (DMSO) solvate to the original Lenvima. The drug's supporting document has been submitted and it was approved by the Ministry of
- Policy
- Comb cancer therapy issue has been resolved
- by Whang, byung-woo Apr 21, 2025 05:53am
- Changes will be brought to the health system as a patient's existing co-payment amount will remain the same for ongoing chemotherapy when a reimbursed cancer drug combined with a newly developed, non-reimbursed new drug. Previously, insurance coverage for combination therapy comprising two drugs was unavailable, placing a financial burden on
- Policy
- CKD approved for Januvia+Jardiance+metformin combo
- by Lee, Hye-Kyung Apr 18, 2025 05:59am
- Chong Kun Dang, which launched a combination drug that combines the DPP-4 inhibitor 'Januvia (sitagliptin)' and the SGLT-2 inhibitor 'Jardiance (empagliflozin),' has received approval for a triple combination drug that adds metformin to the same combination just one week later. On the 16th, the Ministry of Food and Drug Safety approved
- Policy
- Original-generic collusion prevention law introduced
- by Lee, Jeong-Hwan Apr 18, 2025 05:59am
- A bill has been proposed in the National Assembly to prevent collusion between original drug manufacturers and generic drug manufacturers from maintaining the domestic sales status of original drugs through illegal means. On the 17th, Representative Young-Seok Seo (Gyeonggi Province, Bucheon City, National Assembly Health and Welfare Commi
- Policy
- Co-payments retained for non-reimb drug+reimb drug comb
- by Lee, Jeong-Hwan Apr 18, 2025 05:57am
- The Ministry of Health and Welfare (MOHW) has decided that, even if an additional or combination anticancer drug is added to a chemotherapy regimen already covered by health insurance, the initial chemotherapy will continue to be subject to the patient’s existing co-payment. Boehringer Ingelheim’s idiopathic pulmonary fibrosis and fibro
- Policy
- Will a 'Duodart' generic for prostatate drug be available?
- by Lee, Hye-Kyung Apr 16, 2025 05:55am
- A generic version of GSK's benign prostatic hyperplasia (BPH) combination product 'Duodart Capsule (dutasteride·tamsulosin hydrochloride),' which drove the success of the combination drug market for urology in Korea, is now under development. On the 14th, the Ministry of Food and Drug Safety (MFDS) approved an open-label, randomized, two
- Policy
- Global pharma proposes 'indication-based pricing system'
- by Lee, Jeong-Hwan Apr 16, 2025 05:55am
- Overseas global pharmaceutical companies with subsidiaries in Korea are currently voicing the adoption of policies aimed at resolving 'reimbursement inequities' for therapies for severe and rare diseases and implementing an 'indication-based pricing system' amid an early presidential election. While the Korean government maintains that an
