Regulatory Updates
Sep 7, 2026•1 min read
Human Tissue Distributor A Receives One-Month Suspension for SOP Breach
Company A failed to follow its own tissue handling SOPs during frozen tissue redistribution and was suspended by Korea’s MFDS from Aug 31 to Sep 30.
Regulatory Updates
Sep 6, 2026•1 min read
TDS Farm fined 19.35 million KRW for record‑keeping violations in Kataplasmaze contract manufacturing
South Korea's MFDS fined TDS Farm 19.35 million KRW, replacing a 15‑day production halt for the Kataplasmaze formulation after finding missing concurrent manufacturing records.
Regulatory Updates
Sep 5, 2026•1 min read
Pharmacies Risk Prescription Errors by Misreading Patient Names, Highlights Recent Commentary
A recent KPA News piece notes that pharmacies sometimes dispense medication after misreading a patient’s name on prescriptions, echoing a lyric from miss A’s song.
Regulatory Updates
Sep 3, 2026•1 min read
MHRA publishes field safety notices for medical devices (24‑28 Aug 2026)
The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.
Regulatory Updates
Sep 1, 2026•1 min read
China NHSA uncovers signature fraud by foreign innovator in VBP bid
China's NHSA revealed that a foreign innovative pharma company falsified over 80% of doctor signatures in a price‑bid petition, prompting warnings amid VBP expansion.
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Regulatory Updates
Aug 30, 2026•1 min read
Yuhan Yanghang Upholds Global Ethical Standards in Clinical Trials
Yuhan Yanghang says it follows global bio‑ethics standards, using ICH guidelines and the Helsinki Declaration, and continuously monitors adverse events to protect trial participants.
Regulatory Updates
Aug 30, 2026•1 min read
Calls to Extend Mandatory Serial‑Number Reporting to OTC Medicines
Industry groups argue that applying the serial‑number reporting system used for prescription drugs to over‑the‑counter medicines would enable electronic tracking of batch numbers and expiry dates, improving returns efficiency and distribution transparency.
Regulatory Updates
Aug 30, 2026•1 min read
2025 Korean Local Governments Miss Disability Employment Quotas
Analysis shows 139 of 226 Korean local governments failed to meet mandatory disability employment rates for 2025.
Regulatory Updates
Aug 30, 2026•1 min read
Health Canada Issues Labeling Alert for Pro+ Model p7924a13
Health Canada reports that the UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatible bed frame use.
Regulatory Updates
Aug 26, 2026•1 min read
Sanofi’s Genzyme Ireland unit receives FDA Form 483, faces further reprimand
FDA inspectors issued a Form 483 to Sanofi’s Genzyme Ireland after a 2026 site visit, prompting additional regulatory reprimand.
Regulatory Updates
Aug 25, 2026•1 min read
Eli Lilly threatens hospitals with loss of 340B discounts over data submission deadline
Eli Lilly gave hospitals a June 8 deadline to submit 340B data, warning loss of discounts; hospital groups call the move unlawful.
Regulatory Updates
Aug 24, 2026•1 min read
FDA Recall: Foreign Substances and Heavy Metals Detected in Product
FDA has recalled a product after routine stability testing revealed visible foreign substances, including heavy metals such as chromium and titanium, and inactive components.