- Policy
- MFDS, "Increase in fees will expedite biosimilar approval"
- by Lee, Tak-Sun Sep 18, 2025 06:02am
- The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees." The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees. The MFDS issued an administrative announcement on September
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies &8211; Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussin
- Policy
- Bill bans remote narcotics and hair loss drug prescriptions
- by Lee, Jeong-Hwan Sep 17, 2025 06:10am
- A partial amendment to the Medical Service Act was introduced in the National Assembly on the 16th, mandating that physicians check the Drug Utilization Review (DUR) system when prescribing via telemedicine. The rule applies to high-risk drugs such as narcotics, psychotropics, anti-obesity drugs like Wegovy, hair loss treatments, and isotret
- Policy
- Spray formulation of 'nicotine' wins nod in KOR as OTC
- by Lee, Tak-Sun Sep 16, 2025 06:10am
- A spray formulation containing nicotine, which is used as a smoking cessation aid, received its first approval in Korea. The nicotine spray was previously discussed for classification as a prescription drug in 2019, but this time it obtained approval as an over-the-counter (OTC) drug that is exempt from safety and efficacy review. Spray fo
- Policy
- US pressures MFNs to cut drug prices
- by Lee, Jeong-Hwan Sep 16, 2025 06:09am
- As the US Trump administration pushes hard for Most Favored Nation (MFN) drug pricing policies, voices are growing within the industry that Korea should mitigate trade pressure by expanding the “risk-sharing agreement (RSA),” the key tool used during drug pricing negotiations in the reimbursement process. Industry representatives are a
- Policy
- "Gov't actively supports the development of new drugs"
- by Lee, Jeong-Hwan Sep 16, 2025 06:08am
- The Ministry of Health and Welfare (MOHW) explained that its establishment of a first-ever 'Phase 3 Specialized Fund' as one of its budget projects for next year is the result of government's commitment to creating innovative new drugs in Korea. The MOHW also announced that it would first design a specific business model for the 'Loan Sys
- Policy
- Jardaince patent expires Oct 23…over 400 generics expected
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- As the substance patent for Jardiance (empagliflozin, Boehringer), an SGLT2 inhibitor for the treatment of diabetes, is expiring next month (October 23), over 400 generic drugs are expected to be introduced to the market. Notably, domestic pharmaceutical companies in Korea have developed empagliflozin + metformin extended-release tablets
- Policy
- Reimbursement review is underway for 'Ozempic'
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- 'Ozempic (semaglutide, Novo Nordisk),' a diabetes treatment with the same active ingredient as the injectable Wegovy, has been reapplied for National Health Insurance reimbursement. Novo Nordisk submitted a reimbursement application for Ozempic to the Health Insurance Review & Assessment Service (HIRA) in the first half of this year, and
- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications.
- Policy
- MOHW will reform system for certifying innovative companies
- by Lee, Jeong-Hwan Sep 12, 2025 06:18am
- The Ministry of Health and Welfare (MOHW) plans to announce a legislative notice in October for reforms to the Korea Innovative Pharmaceutical Company certification system, aiming to implement the changes in January next year. The reform plan includes converting the certification system into a point-based structure and establishing separa
