Actualizaciones regulatorias

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.

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.

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.

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.

KCDC finalizes procurement of 4.84 million doses of WHO/FDA/EMA‑recommended XFG strain vaccine for the 2026‑2027 COVID‑19 vaccination campaign.

ICU Medical Canada is recalling IV sets with potential discoloration in the drip chamber; products remain usable per facility protocol.

ICU Medical Canada is recalling certain IV sets because discoloration may appear in the drip chamber, though they remain usable per protocol.

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.