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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
Potential Pulmonary Aspiration Risk with GLP-1 Agonists During Anaesthesia
Healthcare professionals warned of pulmonary aspiration risk in patients on GLP-1 or dual GIP/GLP-1 agonists undergoing general anaesthesia or deep sedation.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
CHM Removes Specialist Review for Men Already on Valproate, Retains for New Patients Under 55
The Commission on Human Medicines says men already taking valproate no longer need a specialist review, while the requirement stays for patients under 55 starting the drug.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Publishes Summary of Recent Medicine and Device Safety Letters
The UK Medicines and Healthcare products Regulatory Agency (MHRA) released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Removes Post‑Operative Pain Indication for All Prolonged‑Release Opioids
The MHRA has withdrawn the licence indication for post‑operative pain from all prolonged‑release opioids, citing heightened risk of persistent use and opioid‑induced respiratory complications.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Issues New Recommendations for Fezolinetant to Mitigate Liver Injury Risk
MHRA warns that fezolinetant can cause drug‑induced liver injury and advises liver function monitoring before and during treatment.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA warns of severe asthma risk from overuse of short‑acting β2‑agonists
The MHRA reminds healthcare professionals and patients that overusing short‑acting β2‑agonists can trigger severe asthma attacks and increase mortality, even with maintenance therapy.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Alerts to Infrequent Psychological Side Effects of Kaftrio in Cystic Fibrosis
MHRA notes rare reports of anxiety, low mood, sleep disturbance, poor concentration and forgetfulness in CF patients using Kaftrio, urging clinicians to monitor patients.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Alerts to Risk of Intrahepatic Cholestasis of Pregnancy with Thiopurine Drugs
The MHRA notes rare cases of intrahepatic cholestasis of pregnancy in patients using azathioprine and other thiopurines, highlighting a class‑wide risk.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Publishes Updated Safety and Educational Materials
MHRA releases new safety and educational resources to support regulatory measures from the 2023 Patient Safety Alert and 2024 Drug Safety Update.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Reaffirms Paracetamol Safety During Pregnancy, No Autism Link Found
MHRA reminds that there is no evidence linking paracetamol use in pregnancy to autism, reaffirming it as the first‑choice pain reliever for pregnant women.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA publishes Field Safety Notices for 17‑21 August 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices covering 17‑21 August 2026.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA adds IIH warning to mesalazine product information
The MHRA notes rare cases of idiopathic intracranial hypertension in mesalazine users and will update product information with a warning.