規制動向

Korea’s Central Pharmaceutical Review Committee says AstroGen’s autism‑treatment syrup lacks sufficient pre‑specified data for approval, despite recognized unmet need.

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.

Pharmacist groups in South Korea warn that the swift expansion of warehouse‑type pharmacies and disputes involving herbal pharmacists threaten their professional survival, calling for urgent regulatory action.

Bills to tighten regulation of warehouse‑type pharmacies and grant special police powers are awaiting review, but the National Assembly Health and Welfare Committee remains inactive, delaying legislation.

The Korea Pharmaceutical Safety Management Agency will run a mandatory advanced course for drug safety managers on July 9‑10, 2026 at Post Tower, covering post‑marketing safety responsibilities.

A 296‑day relay demonstration in front of Seoul’s Blue House, attended by pharmacy leaders and students, urged the government and parliament to overhaul the herbal pharmacist licensing system.

The FDA has paused its real‑time release of complete response letters after a citizen petition, with HHS reviewing the procedure.

China's NHSA revealed that a foreign innovative pharma company falsified over 80% of doctor signatures in a price‑bid petition, prompting warnings amid VBP expansion.

South Korea's National Assembly is advancing Pharmacy Act amendments to curb external capital influence, limit naming and prevent duplicate operations of warehouse‑type and corporate network pharmacies.

Bonofrazan fumarate, a P‑CAB ulcer medication, has begun price negotiations with Korea’s Health Insurance Review & Assessment Service, drawing industry attention to potential patent and reimbursement impacts.

The FDA has approved RESTORIL, a prescription oral temazepam capsule from SpecGx LLC, available in 7.5‑30 mg strengths under application NDA018163.

The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.