Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Lawmakers Propose Nursing Act Amendment to Address Workplace Bullying in Korea
Lawmaker Lee Soo-jin introduced a bill to empower the Nursing Workforce Support Center to prevent and aid recovery from workplace bullying, after a nurse's death linked to such abuse.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Huons En’s Hagocho Extract Powder Approved as Functional Ingredient for Prostate Health
Huons En, a Huons Group affiliate, secured individual functional ingredient approval (No. 2026-21) from South Korea's MFDS for its Hagocho extract powder, supporting prostate health.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Qurocell's CAR‑T therapy Rimcato clears HIRA severe disease review for insurance coverage
Qurocell announced its CAR‑T drug Rimcato has passed the HIRA Severe Disease Review Committee, clearing the first hurdle for national health‑insurance reimbursement.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
MFDS Expands Rehab Linkage for Drug Addicts, Adds 1342 Hotline in 54 Prisons
South Korea's MFDS announced expanded rehabilitation support for drug addicts, linking correctional facilities with community centers and extending the 24‑hour 1342 counseling hotline to 54 prisons.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Kennedy Jr's MAHA Policy Drives Retail Pharmacy Shift
The 'Make America Healthy Again' initiative led by HHS Secretary Robert F. Kennedy Jr is prompting U.S. neighborhood pharmacies to move beyond dispensing toward preventive medicine, with PBM reforms offering a potential lifeline.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Parliamentary Stalemate Hinders Health Committee Activities in South Korea
Party disagreement stalls National Assembly composition, raising questions about the resumption of health‑related committees and pending legislation.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
KPA Continues 294-Day Relay Protest Demanding Herbal Pharmacist Licensure Clarification
The Korean Pharmaceutical Association held its 294th day relay protest on the 8th, urging the government to clarify herbal pharmacist licensing and improve related regulations.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Daewoong Pharmaceutical Initiates Phase 1 Trials of Olmesartan‑Indapamide Triple Antihypertensive
Daewoong Pharma received MFDS approval for two Phase 1 studies of its olmesartan‑amlodipine‑indapamide combo (DWJ1622), assessing PK and safety in fasting (44) and fed (36) healthy adults.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Korean govt confirms 1 trillion won health‑insurance fund not from generic drug savings
The government reiterated that the 1 trillion won additional funding for health‑insurance fee‑structure reform will not draw on savings from generic drug price cuts, but from reserves, premiums and treasury support.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
KPA Announces Health Insurance Reimbursement Halt for DiOctahexdylsMechtaite in Children from July 2026
The Korean Pharmaceutical Association warned pharmacists that, following MFDS approval changes, the pediatric use of DiOctahexdylsMechtaite formulations is prohibited and health‑insurance coverage will cease for prescriptions from July 6 2026.
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Seoul Court upholds 1‑year suspension of exception pharmacy for refusing health ministry inspection
The Seoul Administrative Court ruled that a 1‑year suspension of a pharmacy operating under the drug‑separation exception in a medically underserved area is justified after it refused a Ministry of Health and Welfare on‑site inspection.
1
Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Korean Health Ministry Opens Recruitment for Community Primary Care Innovation Pilot
The Ministry of Health and Welfare will accept applications from August 9 to August 5 for medical institutions to join a pilot project delivering comprehensive preventive and care services at neighborhood clinics.