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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
20% of Pharmacy Closures in 2024 Involved 20‑Year‑Old Pharmacies
Ministry data shows about 600 pharmacies closed Jan‑Sep 2024, with 124 (20.7%) having operated for 20 years or more.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Korean Health Care Alliance protests 14.4% national health insurance support rate
The Health Care Organizations Union criticizes the government's decision to set next year's health insurance national support at 14.4%, calling it an insult to workers and low‑income citizens.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Dementia Patient Missing Reports Reach 73,313; Fingerprint Pre‑Registration Stagnates at 50.2%
Data from police and health ministry show 73,313 dementia‑patient missing reports from 2022 to June 2024, while cumulative fingerprint pre‑registration remains at 50.2%.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Korean Lawmaker Proposes Food Hygiene Act Amendment to Boost 2025 Food Exports
Lawmaker Park Yong‑gap introduced a bill to amend the Food Hygiene Act, aiming to support overseas expansion of Korea’s food industry projected to export $13.62 billion in 2025.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Guro‑gu Pharmaceutical Association Urges Caution on Expanding Telemedicine Prescription Delivery
The Guro‑gu Pharmacy Association delivered local pharmacists’ concerns to the National Assembly, warning that a full rollout of remote prescription delivery could impact community pharmacy networks and patient safety.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Kyung Hee University Holds RWD‑Pharmacometrics Training for MFDS Officials
Kyung Hee University’s Department of Regulatory Science, together with Catholic University and the MFDS, completed a RWD‑PMX integration training, certifying 28 participants.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Kyungdong Pharma, Aul Bio Submit IND for Monthly Long-Acting Semaglutide Injection (AUL009)
Kyungdong Pharmaceutical and Aul Bio have filed an IND with South Korea’s MFDS for phase‑1 testing of AUL009, a monthly long‑acting semaglutide injection using the ExTenna™ platform.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
BuKwang Pharma's subsidiary Korea Union Pharma completes court rehabilitation, business normalization expected
The Seoul court has officially ended the rehabilitation procedure for Korea Union Pharma, allowing BuKwang Pharma to accelerate business normalization.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
KADA to Deploy 8 Doping Control Officers to Asian Games in Nagoya
KADA will send eight officials to support doping control at the Asian Games in Nagoya, Japan, from Sep 19 to Oct 4, joining a total of 44 international officers.
UPDATED
Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
South Korea Pre‑Pregnancy Support Leaves Thousands Unpaid for Fertility Tests
Analysis of Seoul data shows over 70,000 applicants for fertility test subsidies, but more than 4,000 have not received the test fee payment.
UPDATED
Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
Health Insurance Covers Duochem Bio's PSMA PET-CT Test for Prostate Cancer
Duochem Bio's PSMA-targeted PET-CT radiopharmaceutical ‘Prostasic’ is now reimbursed under South Korea’s health insurance, lowering costs for patients with moderate‑to‑high metastasis risk.
UPDATED
Regulatorische Updates
13. Sept. 2026•1 Min. Lesezeit
South Korea’s Global Regulatory Harmonization Center Designated WHO Cooperation Center
The MFDS Global Regulatory Harmonization Center has been named the first WHO‑recognized Cooperation Center for strengthening medical product regulatory systems and training, expanding global harmonization efforts.