Regulatory Updates
Sep 27, 2026•1 min read
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.
Regulatory Updates
Sep 13, 2026•1 min read
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.
Regulatory Updates
Sep 8, 2026•1 min read
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.
Regulatory Updates
Sep 2, 2026•1 min read
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.
Regulatory Updates
Sep 1, 2026•1 min read
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.
Regulatory Updates
Aug 28, 2026•1 min read
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.
Regulatory Updates
Aug 28, 2026•1 min read
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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Regulatory Updates
Aug 27, 2026•1 min read
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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