Regulatorische Updates

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.

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.

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.

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.

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.

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.

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.

Analysis shows 139 of 226 Korean local governments failed to meet mandatory disability employment rates for 2025.

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.

FDA inspectors issued a Form 483 to Sanofi’s Genzyme Ireland after a 2026 site visit, prompting additional regulatory reprimand.

Eli Lilly gave hospitals a June 8 deadline to submit 340B data, warning loss of discounts; hospital groups call the move unlawful.

FDA has recalled a product after routine stability testing revealed visible foreign substances, including heavy metals such as chromium and titanium, and inactive components.