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2025-09-19 03:45
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Policy
Improvement to the post-marketing management for pharma
by
Lee, Tak-Sun
Sep 11, 2025 06:11am
A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year. Improvement plans to the actual transaction price-b
Policy
Generic dispensing, collusion ban pass legislative committee
by
Lee, Jeong-Hwan
Sep 11, 2025 06:11am
On September 10, the National Assembly¡¯s Legislation and Judiciary Committee passed two amendments to the Pharmaceutical Affairs Act. One expands the post-notification method for generic substitution at pharmacies to include information systems operated by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Ser
Policy
DREC members¡¯ term extended due to delayed nominations
by
Lee, Tak-Sun
Sep 10, 2025 06:13am
The term of office for members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA), which is responsible for the final drug reimbursement adequacy evaluations, has been extended. Although their term was originally scheduled to end on the 7th, the extension was explained as due t
Policy
Six strengths of obesity drug Mounjaro Quick Pen approved
by
Lee, Hye-Kyung
Sep 8, 2025 06:16am
Following its launch in Korea, Eli Lilly has expanded the product lineup of its obesity treatment Mounjaro (tirzepatide) by receiving approval for the Mounjaro QuickPen formulation. On September 5, the Ministry of Food and Drug Safety approved 6 QuickPen doses: 2.5 mg/0.6 ml, 5 mg/0.6 ml, 7.5 mg/0.6 ml, 10 mg/0.6 ml, 12.5 mg/0.6 ml, and 1
Policy
Savings of KRW 32.6B expected from 2025 'Type-Da' PVA nego
by
Lee, Tak-Sun
Sep 5, 2025 06:20am
The National Health Insurance expenditure is expected to see a savings effect of approximately KRW 32.6 billion due to this year's negotiation for the 'Type-Da' Price-Volume Agreement. This year's negotiated items total 110, comprising 48 active ingredients. The ceiling price of these items has been adjusted as of September 1. Items subjec
Policy
Pilot Drug Approval¡¤Review Coordination Committee extended
by
Lee, Hye-Kyung
Sep 4, 2025 06:10am
The pilot operation period for the Pharmaceutical Approval and Review Coordination Committee will be extended by one year. According to the pharmaceutical industry on September 3, the Ministry of Food and Drug Safety (MFDS) decided to extend the pilot period for the Coordination Committee by one year, starting from August 29. The committee ha
Policy
MFDS allocates KRW 812.2 billion for next year's budget plan
by
Lee, Hye-Kyung
Sep 4, 2025 06:09am
The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) has announced that its budget for 2026 has been set at a total of KRW 812.2 billion, an increase of KRW 63.3 billion (8.4%) from this year's budget of KRW 748.9 billion. This budget plan was focused on facilitating the smooth execution of the new government's national ta
Policy
HIRA "Reimb application of Wegovy has not been filed"
by
Lee, Jeong-Hwan
Sep 4, 2025 06:08am
The Health Insurance Review & Assessment Service (HIRA) announced that it will conduct a fair and swift evaluation if an application for reimbursement is submitted for Novo Nordisk's popular obesity drug, Wegovy (semaglutide). HIRA clarified that since Wegovy's company has not yet applied for reimbursement, HIRA is yet at the stage of de
Policy
Luxturna shows signif improvement in 3 out of 6 patients
by
Lee, Tak-Sun
Sep 3, 2025 06:09am
Luxturna (voretigene neparvovec, Novartis), a one-shot gene therapy that costs approximately KRW 300 million, showed clinically significant changes set by reimbursement criteria in only half of the patients. As indicated in the performance evaluation results disclosed last year, the effectiveness was only 50%. The Health Insurance Revie
Policy
Bill to mandate generic substitutions gains momentum
by
Lee, Jeong-Hwan
Sep 3, 2025 06:09am
On September 2, the ruling party introduced a bill to mandate generic (ingredient-based) prescriptions for medicines with unstable supply. The bill establishes the legal basis for ¡°shortage drugs¡± and allows prescribing by ingredient name instead of brand name. The bill holds significance in that it amends the Pharmaceutical Affairs Ac
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