규제 업데이트

The Ministry of Health and Welfare announced plans to create a dedicated permanent organization to tackle abnormal fake medical treatments, including fee paybacks and advance high‑cost payments.

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.

Health Canada recalls nine Sarclisa single-use vials from three Nova Scotia locations after possible freezing during shipment.

The FDA's ANDA087695 filing for FOLEX injectable methotrexate (25 mg, 50 mg, 100 mg) shows all three products are listed as discontinued.

Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.

The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.

The FDA has approved ANDA085785 for Sandoz’s oral tablet of trifluoperazine hydrochloride, a prescription drug, with multiple manufacturing and labeling approvals spanning 1982‑1999.

The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.

The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.

MFDS approves Latica Eye Drops 5% for adult dry‑eye patients, marking Korea’s 44th domestically developed new drug and expanding treatment options.

Ajou Pharmaceutical, together with G.L. PharmTech, secured MFDS approval for Latica Eye Drops 5% (recopolabone hydrate, code AJU‑S56), marking the company’s first marketed new drug and Korea’s 44th domestically developed new drug for dry eye.

The Ministry of Food and Drug Safety announced several staff transfers and promotions on Sep 4 and Sep 7, 2026, covering food safety, consumer protection and bio‑pharmaceutical divisions.