首页

法规动态

FDA、EMA、TGA 及全球法规动态

#drug safety ×

UPDATED
法规动态
2026年9月25日•1 分钟阅读
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
法规动态
2026年9月17日•1 分钟阅读
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
法规动态
2026年9月14日•1 分钟阅读
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
法规动态
2026年9月14日•1 分钟阅读
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.
18
UPDATED
法规动态
2026年9月14日•1 分钟阅读
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
法规动态
2026年9月10日•1 分钟阅读
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
法规动态
2026年9月8日•1 分钟阅读
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
法规动态
2026年9月5日•1 分钟阅读
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
法规动态
2026年9月4日•1 分钟阅读
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
法规动态
2026年9月3日•1 分钟阅读
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
法规动态
2026年9月2日•1 分钟阅读
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
法规动态
2026年9月1日•1 分钟阅读
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.