Actualizaciones regulatorias

The Suwon City Pharmacists Association conducted its mid‑year audit on March 8, reviewing accounting and operations while discussing challenges such as warehouse‑type pharmacies and drug shortages.

PMDA outlines resources, consultations, and guidelines to support developers of software as a medical device (SaMD) in Japan.

On July 10, 2026, the Korean Ministry of Health and Welfare announced the director‑level transfer of Kim Hyun-sook to the role of Population and Child Policy Officer.

Korea’s first CAR‑T drug Limkato has cleared its initial health‑insurance coverage review, paving the way for prescriptions and sales from the second half of 2024.

Legislative changes aimed at improving narcotics prescription management have led to a measurable drop in reported misuse cases among medical professionals in 2026, according to Rep. Jeon Jin-suk.

G-Cell announced that its immune cell therapy ImmuneCell LC has been officially classified by WHO under ATC code L01XL17 for antineoplastic cell and gene therapy.

Inspections by Korea's MFDS show a sharp increase in companies labeling skin‑boosting cosmetics with PDRN, rising from 7 cases in 2023 to 39 in 2025.

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.

A recent National Assembly Budget Office report recommends boosting national university hospitals and reorganizing regional responsibility medical systems, which could benefit nearby pharmacies.

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

Seoul Administrative Court ruled in favor of R&L Regenerative Medicine, canceling the MFDS’s 2025 rejection of Jointstem, a stem‑cell treatment for osteoarthritis.

A Korean pharmacists' group urges scaling back the convenience‑store standby drug system after the key product 지사제 is barred for under‑19 use.