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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#drug safety ×

UPDATED
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
Pharmacies urged to lead systematic monitoring of OTC drug safety
Experts highlight need for pharmacy-based pharmacovigilance for over‑the‑counter medicines due to hidden adverse events.
UPDATED
Regulatorische Updates
17. Sept. 2026•1 Min. Lesezeit
Online Mall Sells Three OTC Drugs Despite Recent Pharmacy Act Fine, Raising Safety Concerns
Three OTC medicines were found listed for sale on an online shop, even after a recent fine for illegal online dispensing, highlighting gaps in drug safety oversight.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Seoul Pharmacists Association Calls for Fast Legislative Action on Pharmacy Independence and Drug Safety
The Seoul Pharmacists Association delivered a petition to the National Assembly urging prompt review of pending pharmacist‑related bills and stressing safety checks before expanding telemedicine drug delivery.
UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
MHRA Field Safety Notices Published 7‑11 Sep 2026
MHRA released several Field Safety Notices between 7‑11 September 2026, covering a platelet factor 4‑heparin antibody IVD and an orthopaedic fixation plate among others.
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UPDATED
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Severe Drug Reactions Eligible for Compensation per MFDS Review Committee
MFDS confirms compensation for patients with Stevens‑Johnson syndrome, anaphylactic shock and Dress syndrome after specific drug use.
UPDATED
Regulatorische Updates
10. Sept. 2026•1 Min. Lesezeit
MFDS updates safety labeling for triptolide and azathioprine drugs
The Korean MFDS will amend approval labeling for triptolide and azathioprine products, adding severe skin reaction warnings for triptolide and PRES and tremor warnings for azathioprine.
UPDATED
Regulatorische Updates
8. Sept. 2026•1 Min. Lesezeit
South Korea Tightens Penalties for Drug-Induced Drowsy Driving, Emphasizes Pharmacy Warnings
Following a high‑profile drowsy‑driving case, South Korea revised its law in April 2026, raising penalties to up to 5 years imprisonment or 20 million KRW fine and stressing pharmacy drowsiness warnings.
UPDATED
Regulatorische Updates
5. Sept. 2026•1 Min. Lesezeit
Ewha Pharmacy Alumni Association adopts resolution on safe medication use
The alumni group held its Aug 22 meeting, discussing OTC expansion, relaxed sales rules in drug‑free zones, and telemedicine‑driven delivery, and adopted a safety‑focused resolution.
UPDATED
Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Korea Pharmaceutical Safety Agency Highlights Updated Narcotics Regulations at KMA 2026 Conference
The agency announced expanded verification of medical narcotics to include zolpidem and revised safety standards for narcotic analgesics, promoting the changes at the KMA 2026 conference.
UPDATED
Regulatorische Updates
3. Sept. 2026•1 Min. Lesezeit
KPA reports 283 OTC adverse events, highlighting risks with common cold medicines
Analysis of 283 OTC adverse cases reported over three months shows cold medicines, oral antihistamines and decongestants most frequently involved.
UPDATED
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.
UPDATED
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.