Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
MHRA warns of fatal embolism risk when parenteral nutrition administered without filter
The MHRA reports that delivering parenteral nutrition without a filter has caused adverse incidents, including a fatal embolism.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
MHRA alerts: Use filters for parenteral nutrition to prevent fatal embolism
The MHRA reports that delivering parenteral nutrition without a filter has caused adverse incidents, including a fatal embolism, urging filter use in all care settings.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Pharmacists Hold 299th Day Relay Protest Demanding Reform of Korean Herbal Pharmacist System
A relay protest by Korean pharmacists entered its 299th day, with KPA leaders and pharmacy students gathering in Seoul to call for government action on the Han‑yak‑sa licensing issue.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
South Korean Bill Aims to Support Small Businesses at Risk of Closure, Including Pharmacies
A bill introduced by lawmaker Lee Jong-bae seeks to expand support from closed small businesses to those facing closure risk, offering early diagnostics, debt restructuring and credit recovery, potentially benefiting pharmacies.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
MFDS approves zinc citrate and iron chelate as new nutrient‑fortification ingredients
The Korean MFDS has designated zinc citrate and iron chelate as approved nutrient‑fortification agents for foods and health supplements, effective Jan 1 2028.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
South Korea Tightens Penalties for Drug‑Impaired Driving After Apgujeong Rolls‑Royce Incident
The August 2023 Apgujeong Rolls‑Royce crash, involving a driver under the influence of seven prescription psychoactive drugs, spurred stricter penalties for drug‑impaired driving under Korea’s revised road traffic law.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Samchundang Pharma receives manufacturing suspension over test record violations and recall plan failure
Samchundang Pharmaceutical was ordered to halt production after the MFDS found irregularities in a potency test and a failure to submit a recall plan for its contracted Lefurozin syrup.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Kim Tae‑yong Pharmacist Wins 2026 OTC Adverse‑Event Reporting Event
Pharmacist Kim Tae‑yong of Seoul’s Smile Pharmacy was named top member in the 2026 OTC adverse‑event reporting activation event, marking his second consecutive win.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
FDA Approves Pfizer/Astellas Padcev and Merck Keytruda Combo for All MIBC Patients
The FDA has approved the Padcev and Keytruda combination as the first muscle‑invasive bladder cancer therapy usable irrespective of cisplatin eligibility, for both neoadjuvant and adjuvant settings.
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Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
FDA approves five new products in June, spanning cell therapy to biosimilars
The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Special Police Authority Bill Revived Amid New Pharmacy Act Amendments Targeting Warehouse Pharmacies
Recent Pharmacy Act amendment proposals to curb warehouse‑type pharmacies have renewed focus on a special police authority bill introduced a month ago, emphasizing the need for effective enforcement.
Regulatorische Updates
1. Sept. 2026•1 Min. Lesezeit
Korean Court Upholds Pharmacist's Front‑Hospital Pharmacy Rights, Rejects Right‑Fee Refund
The Suwon District Court dismissed a claim to return a 130 million KRW right‑fee, affirming that the operating right of a front‑of‑hospital pharmacy belongs to the original pharmacist.