Regulatorische Updates

The Korean Ministry of Food and Drug Safety inspected the pilot K‑NASS system, aiming to detect misuse and illegal distribution of medical narcotics more rapidly.

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

The first regular Health and Welfare Committee meeting showed sharp partisan clashes, focusing on the MFDS’s responsibility linked to the Justice Minister nominee.

The Korean MFDS announced a meeting on Oct 10 to guide herbal medicine makers on the new standard decoction definition effective Sep 2024 and share change‑approval procedures.

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.

The Korean Food & Drug Administration tested 100 top‑selling hand sanitizers and found four failing the ingredient‑content standards, prompting sales suspension, recall and disposal.

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

South Korea's MFDS plans to finish designating GLP‑1 obesity treatments such as Wegovy and Mounjaro as ‘drugs with potential for abuse’ by September, requiring prescription‑only sales and mandatory labeling.

The Global Cosmetics Regulatory Agency Council (GCORAS) was officially inaugurated in Seoul, led by South Korea’s Ministry of Food and Drug Safety, with meetings running through Sept 9.

South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.

The Ministry of Food and Drug Safety disclosed that Kyungbang Shinyak received seven GMP observations in facility equipment and manufacturing, all categorized as "Other" with no major issues.

The government plans to consolidate the Korean Rare Essential Medicines Center, the Pharmaceutical Safety Management Agency and the Vaccine Safety Technology Support Center under a new Korean Pharmaceutical Safety Agency.