Regulatorische Updates

The Ministry of Food and Drug Safety has recalled specific batches of Daewoong Pharmaceutical’s ezetimibe/rosuvastatin tablets and products from YS Life Science due to packaging label discrepancies.

The European Medicines Agency has started a voluntary data submission pilot to share data generated using New Approach Methodologies (NAMs).

South Korea's MFDS will embed the 3R principle in biologics quality‑test standards and introduce a CHO cell‑culture alternative for pertussis vaccine toxicity testing, reducing animal use.

The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.

The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.

The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.

The FDA has approved ANDA 077351, covering a range of oral acid‑reducer and heartburn‑prevention products listed under various brand names.

The FDA has approved several labeling supplement submissions for discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) under ANDA 076765.

The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.

FDA issued a Complete Response Letter for HLB’s ribociclib NDA, citing cGMP deficiencies at the Chinese Hengrui manufacturing site.

Korean companies have secured 19 of the 87 FDA‑approved biosimilars through June 2026, placing Korea second worldwide after the United States.

South Korea's MFDS announced expanded rehabilitation support for drug addicts, linking correctional facilities with community centers and extending the 24‑hour 1342 counseling hotline to 54 prisons.