規制動向

MFDS says statistical significance alone isn’t enough for functional food ingredient approval; proper trial design and consistent functional outcomes are required.

South Korea's MFDS has detailed new review criteria and updated guidelines for digital therapeutic device trials covering seven mental‑health and substance‑use disorders.

MFDS’ recent survey identified corrective findings at five hospitals, while Korea University Medical Center had no issues.

Il-yang Pharmaceutical terminated its supply and technology export agreement with Russia's R‑Pharm for the domestic new drug Suphect (radotinib) after no local trials, while pursuing Chinese approval.

Large-scale comparative clinical efficacy studies are being scaled back, with global regulators emphasizing advanced quality analysis and PK data, according to a KoBIA report.

Kyungdong Pharmaceutical and Aul Bio have filed an IND with South Korea’s MFDS for phase‑1 testing of AUL009, a monthly long‑acting semaglutide injection using the ExTenna™ platform.

Oncogenic Therapeutics received a US patent decision for Nesuparib’s high‑purity crystal form and its manufacturing process, extending protection through May 2042 ahead of US clinical trials.

Intensifying global drug development competition highlights the need for strong patents, timed disclosures and strategic workarounds as China’s fast‑follower biotech sector accelerates patient recruitment and cuts clinical costs.

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

The PMDA‑ATC & US FDA Pediatric Review Seminar held June 23‑25, 2026 gathered 27 regulators from 10 Asian and African nations to discuss pediatric drug development, guidelines, and ethical trial considerations.

Yuhan Yanghang says it follows global bio‑ethics standards, using ICH guidelines and the Helsinki Declaration, and continuously monitors adverse events to protect trial participants.

The PMDA published seven English translations of notifications and administrative notices related to pediatric drug development, including a revision of the planning guidance for adult drug programs.