- Policy
- PVA monitoring for high-priced drugs conducted in Q4
- by Jung, Heung-Jun Sep 25, 2025 06:12am
- High-priced anticancer drugs, including Keytruda and Opdivo, have been placed under monitoring for price-volume agreements (PVA, Type A·B) in the 4th quarter. On the 23rd, the National Health Insurance Service (NHIS) released ‘prior information on the Q4 monitoring list for drugs subject to PVA (Type A·B).’ A total of 111 items wer
- Policy
- Parties disagree with non-face-to-face medical service bill
- by Lee, Jeong-Hwan Sep 24, 2025 06:25am
- The government's effort to pass a "one-point" bill on non-face-to-face medical services through the National Assembly's Health and Welfare Committee, Judiciary Committee, and plenary session this month has failed. The chief secretary of the Democratic Party of Korea, Lee Su-jin, on behalf of Vice Minister of Health and Welfare Lee Hyung-ho
- Policy
- MFDS to review Tylenol safety following Trump’s remarks
- by Lee, Tak-Sun Sep 24, 2025 06:24am
- The Ministry of Food and Drug Safety (MFDS) announced that it will carefully review safety concerns regarding Tylenol, following remarks made by US President Donald Trump. On the 22nd (local time), President Trump held a press conference at the White House, stating, “Acetaminophen, widely known as Tylenol, may increase the risk of autism
- Policy
- Contraindication guidelines to flu vaccine cut down in KOR
- by Lee, Tak-Sun Sep 23, 2025 06:07am
- The Ministry of Food and Drug Safety (MFDS) plans to significantly reduce the list of contraindications for influenza (flu) vaccines. The MFDS has decided to create a new set of recommended guidelines because the previous contraindications were deemed inconsistent with current clinical practice and international standards. The MFDS coll
- Policy
- Will access to aHUS drugs improve in Korea?
- by Jung, Heung-Jun Sep 23, 2025 06:06am
- The prior approval criteria for receiving reimbursement of atypical hemolytic uremic syndrome (aHUS) drugs, which had long been criticized for impeding patient access, have been improved. This issue was raised during last year’s National Assembly audit as well. At that time, Rep. Yoon Kim (Democratic Party of Korea) pointed out the low a
- Policy
- Bylvay will be reimbursed from next month in Korea
- by Lee, Jeong-Hwan Sep 19, 2025 06:12am
- Bylvay Cap (odevixibat), a treatment for progressive familial intrahepatic cholestasis (PFIC), will be covered by Korea’s National Health Insurance starting on October 1. Bylvay Cap was selected as the first drug for the “Approval&8211;Evaluation&8211;Negotiation parallel pilot program,” and underwent an expedited reimbursement process.
- 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
