Regulatorische Updates

HIRA has appointed Ajou University Prof. Park Rae‑woong, an expert in health data and AI, as the 9th Chair of its Clinical Review Committee for a two‑year term.

Professor Park Rae-woong of Ajou University, an expert in health data and AI, has been appointed as the new chair of the Health Insurance Review & Assessment Service's Clinical Review Committee for a two‑year term starting Sep 14, 2026.

Menarini Group will pay €62 million upfront to Gan & Lee Pharmaceuticals for rights to develop and commercialise the GLP‑1 candidate bofanglutide in 39 European countries, with total contract value up to $771 million.

The Korean Pharmaceutical Association announced it will intensify its response to curb the expansion of prescription drug delivery via telemedicine and increase safety‑stock medicines, moving forward with its emergency committee.

South Korea, now the world’s second‑largest cosmetics exporter, is focusing on aligning international regulations to avoid new trade hurdles as AI and biotech integrate into products.

The Pharmaceutical Industry Innovation Public-Private Council is evaluating a ban on re-delegation and tighter reporting for drug promotional sales reps, with three proposals likely to be codified.

A Korean public petition has quickly amassed over 25,000 signatures, urging the government to withdraw the expanded drug‑delivery policy linked to telemedicine before the Oct 3 deadline.

The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.

FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.

FDA has approved ANDA083386 for chlorpromazine hydrochloride tablets (10 mg) manufactured by Upsher‑Smith Laboratories, listed as a prescription oral drug.

FDA approved labeling and manufacturing submissions for ANDA081008 covering the oral tablet STRIFON FORTE DSC (500 mg chlorzoxazone) by Fern Dale Labs; the product is now discontinued.

The FDA has processed application ANDA084026 for Watson Labs' oral chlorothiazide 500 mg tablet, currently listed as discontinued.