規制動向
2026年9月27日•1分で読めます
Sanofi-Aventis Canada Recalls Certain Insulin Pens and Cartridges Over Freezing Risk
Sanofi-Aventis Canada is recalling 1,043 insulin pens and cartridges from ~80 Canadian sites after they may have been frozen during shipping, potentially reducing effectiveness.
規制動向
2026年9月13日•1分で読めます
MFDS Sets 2027 Budget of 8.8 bn KRW, Emphasizes AI‑Driven Drug Approval and Global Regulatory Support
South Korea’s MFDS announced a 2027 budget of 8.829 billion KRW, focusing on AI‑based drug approval, global regulatory assistance, and a state‑run stockpile for essential medicines.
規制動向
2026年9月8日•1分で読めます
Essential Medicine Supply Disruption Highlighted in Korea’s 2026 National Audit
The Korean Legislative Research Service flagged essential drug shortages as a key health‑welfare issue in its 2026 National Audit analysis, noting gaps between existing plans and a lack of a health‑security control tower.
規制動向
2026年9月2日•1分で読めます
Celltrion Maintains AAA AEO Certification for Export and Import
Celltrion renewed its AAA‑level AEO certification for both export and import, remaining the only pharma company in Korea with the top customs compliance rating.
規制動向
2026年9月1日•1分で読めます
South Korea Secures 4.84M Doses of XFG COVID-19 Vaccine for 2026-2027 Season
KCDC finalizes procurement of 4.84 million doses of WHO/FDA/EMA‑recommended XFG strain vaccine for the 2026‑2027 COVID‑19 vaccination campaign.
規制動向
2026年8月28日•1分で読めます
ICU Medical Canada Recalls Certain IV Sets Due to Possible Discoloration
ICU Medical Canada is recalling IV sets with potential discoloration in the drip chamber; products remain usable per facility protocol.
規制動向
2026年8月28日•1分で読めます
ICU Medical Canada recalls IV sets due to possible drip chamber discoloration
ICU Medical Canada is recalling certain IV sets because discoloration may appear in the drip chamber, though they remain usable per protocol.
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規制動向
2026年8月27日•1分で読めます
FDA selects Lilly, Regeneron, Fujifilm and four others for PreCheck pilot
The FDA has chosen seven firms, including Eli Lilly, Regeneron and Fujifilm, to join its PreCheck Pilot Program aimed at bolstering U.S. drug manufacturing and supply‑chain resilience.
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