규제 업데이트

FDA has approved ANDA087129 for a 4 mg oral tablet of Cyproheptadine Hydrochloride, sponsored by Strides Pharma Intl, with a history of labeling and manufacturing supplements.

206 Korean civil society organisations say the government’s 2027 integrated care budget is less than a quarter of their demand, urging major increases in funding, infrastructure and staff.

The FDA’s ANDA080195 filing shows that MILES’ injectable potassium chloride products (1–4 mEq/mL) are listed as discontinued.

The UK MHRA has decided to withdraw the marketing authorisation for Tavneos (avacopan) for ANCA-associated vasculitis, halting new patient supply from 1 Sept.

FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.

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 FDA approved ANDA084144 for a 0.5% proparacaine hydrochloride ophthalmic solution (drops) submitted by SOLA BARNES HIND; the product is now discontinued.

The Ministry of Health and Welfare appointed attorney Lee Chang-hoon as the 5th director of the Korea Medical Dispute Mediation and Arbitration Agency, effective Sep 1, 2026.

The FDA record shows Watson Labs' injectable Hydrocortisone Acetate (50 mg/mL) has been discontinued under ANDA085214.

The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.

The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.

At CPHI Korea 2026, experts urged Korean pharma and biotech firms to secure next‑generation modalities, fuse physical AI, and expedite preclinical and data legislation updates.