Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
KPA Issues Alternative Drug List After DiOctahedral Mesylate Pediatric Indication Removed
Following the MFDS removal of the >24‑month pediatric indication for dioctahedral mesylate, the Korean Pharmaceutical Association provided a list of 32 OTC and 15 prescription alternatives for member pharmacies.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
South Korea Secures 4.84M Doses of XFG COVID-19 Vaccine for 2026-2027 Season
KCDC finalizes procurement of 4.84 million doses of WHO/FDA/EMA‑recommended XFG strain vaccine for the 2026‑2027 COVID‑19 vaccination campaign.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korean Pharmacy Association Calls for Full Review of Drug Pricing, Urges Competitive Pricing System
The Korean Pharmaceutical Association for Health Society submitted comments urging the government to overhaul the entire drug price system and introduce a competitive pricing model, rather than merely adjusting generic price rates.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korea Novo Nordisk Pharma’s Alhemo Prefilled Pen Gains MFDS Approval for Hemophilia A & B Prophylaxis
Alhemo® prefilled pen (consiliumab) received MFDS approval for routine prophylaxis in patients 12 years and older with hemophilia A or B, offering a new treatment option in South Korea.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Oral Obesity Drugs Gain Ground as Novo Nordisk and Eli Lilly Secure Approvals in Europe and US
Novo Nordisk’s Wegovy oral formulation received UK approval, while Eli Lilly’s oral orforglipron (Foundayo) was approved in the US, intensifying competition in the expanding obesity drug market.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
FDA Approves Sanofi's Subcutaneous Sarclisa Escena for Multiple Myeloma
Sanofi's subcutaneous formulation of Sarclisa, Sarclisa Escena, received FDA approval, becoming the first injectable oncology drug deliverable via on-body injector.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
South Korea Proposes Multiple Bills to Tighten Narcotics Control and Support Medical Cannabis Production
New legislative drafts aim to mandate driving risk warnings for narcotic drugs, strengthen enforcement measures, curb online illegal sales, and enable domestic cannabis production for medical use.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
South Korea's MFDS orders recall of Daewoong and YS Life Science medicines over packaging label mismatch
The Ministry of Food and Drug Safety has recalled specific batches of Daewoong Pharmaceutical’s ezetimibe/rosuvastatin tablets and products from YS Life Science due to packaging label discrepancies.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korea Resumes Health Insurance Survey to Crack Down on Pharmacy False Claims
The Ministry of Health and Welfare will conduct a 2026 health‑insurance planning survey (Aug‑Oct) targeting pharmacies with frequent false‑claim types, after a two‑year pause.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korea Anti-Corruption Commission rules claim period starts from reimbursement decision date
The National Anti‑Corruption and Civil Rights Commission says the limitation period for health‑insurance claims should be calculated from the reimbursement decision date, not the original treatment date, and urges HIRA to issue new guidelines.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
3rd Pharmacy Agreement Council Meeting to Address Korean Medicine Pharmacist Licensure and Warehouse Pharmacies
The Ministry of Health and Welfare and the Korean Pharmaceutical Association will hold the 3rd Pharmacy Agreement Council meeting in Sejong, focusing on Korean medicine pharmacist licensure scope and warehouse‑type pharmacy issues.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
EMA launches voluntary data submission pilot for New Approach Methodologies
The European Medicines Agency has started a voluntary data submission pilot to share data generated using New Approach Methodologies (NAMs).