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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
NGPod pH Testing Device Withdrawn from UK Market
The NGPod handheld device and sensor for nasogastric tube placement are being withdrawn in the UK after the manufacturer ceased trading; users must quarantine remaining units.
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.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Announces MedSafetyWeek 2025 Theme: ‘We Can All Help Make Medicines Safer’
The MHRA’s annual MedSafetyWeek runs 3‑9 Nov 2025, focusing on the theme ‘we can all help make medicines safer’.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
CHM Endorses Updated Isotretinoin Prescribing Guidance, Seeks Service Feedback
The Commission on Human Medicines has approved new prescribing guidance for isotretinoin and is gathering data from dermatology services for future updates.
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.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA warns of medication error risk with new Rybelsus tablet
MHRA alerts that the transition to a new Rybelsus® tablet formulation, with different labeled doses but bioequivalent, may cause medication errors and patient harm.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Reviews Addiction Warnings for Gabapentinoids, Benzodiazepines and Z‑Drugs
The UK Medicines and Healthcare products Regulatory Agency has re‑examined safety warnings on gabapentin, pregabalin, benzodiazepines and Z‑drugs, with findings published in a Public Assessment Report.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
CHM Endorses Updated Risk‑Minimisation Measures for Isotretinoin
The CHM has endorsed updated risk‑minimisation measures for isotretinoin after reviewing the 2023 measures, urging healthcare professionals to review them.
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA Updates GLP‑1 Agonist Labels with Stronger Pancreatitis Warnings
The MHRA has revised product information for all GLP‑1 and dual GLP‑1/GIP receptor agonists to emphasize the risk of acute pancreatitis, including necrotising and fatal cases.
UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA warns of rare NAION cases linked to semaglutide (Wegovy, Ozempic, Rybelsus)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) notes that non‑arteritic anterior ischemic optic neuropathy (NAION) has been reported very rarely in patients using semaglutide (Wegovy, Ozempic, Rybelsus).
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UPDATED
규제 업데이트
2026년 8월 24일•1분 읽기
MHRA restricts IXCHIQ Chikungunya vaccine use in adults over 60
MHRA’s safety review leads to IXCHIQ vaccine no longer being indicated for adults over 60 years.