規制動向

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.

FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.

Korea Pfizer announced that etanercept (Enbrel) will be reimbursed by national health insurance for severe active non‑radiographic axial spondyloarthritis patients starting September 1, expanding treatment access.

The Korean Medical Association’s special committee denounced the Dongdaemun police’s decision not to prosecute a Korean medicine practitioner for using lidocaine and Opus Dual medical devices, urging a review.

The FDA approved an ANDA (ANDA077678) for a 0.1% mometasone furoate topical lotion submitted by Cosette Pharms NC; the product is listed as discontinued.

The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.

FDA approved ANDA076788 for a Mometasone Furoate 0.1% topical lotion by Sun Pharma Canada; the product is listed as discontinued, with labeling supplements approved in 2015 and 2019.

FDA has approved ANDA 076507 submitted by TARO for oral Fluconazole tablets in 50‑200 mg strengths; all listed products are marked discontinued.

The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.

The Ministry of Health and Welfare says drug delivery should be expanded step‑by‑step and remote medication counseling needs fee incentives, amid strong opposition from the Korean Pharmaceutical Association and consumer groups.

Experts highlighted adult obesity as a chronic disease and national health issue, calling for improved treatment access and a state‑level management system at the ICOMES policy session.

Health Canada has recalled three Organika gummy supplements after discovering they were imported from a foreign manufacturing site not listed on the site licence.