法规动态

The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.

The FDA has approved application ANDA080693 for a prescription 1% hydrocortisone topical cream marketed as HYDROCORTISONE by Fougera Pharm Inc.

The FDA has listed the ANDA 080086 submission for the oral tablet Triple Sulfa, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, as discontinued.

After finalizing its subcommittee, the Health and Welfare Committee is expected to set dates for reviewing pending pharmacy‑related bills, including the Pharmacy External Capital Prevention Act.

The FDA has granted approval for ANDA076316, a prescription injectable sodium chloride 0.9% solution in a plastic container, submitted by GVS TM.

Company A failed to follow its own tissue handling SOPs during frozen tissue redistribution and was suspended by Korea’s MFDS from Aug 31 to Sep 30.

서울시약사회가 비대면진료 의약품 배송 확대와 안전상비의약품 제도 변화, 창고형 약국 확산에 대응해 대한약사회 임시대의원총회 소집을 요구했습니다.

South Korea's MFDS will extend its medical narcotics prescription monitoring system to cover the anesthetic propofol, with checks advisory and alerts for high‑frequency use.

The Korean National Assembly Speaker appointed four advisors—former MFDS head Jeong Seung among them—to guide policy on innovation growth, finance, future growth, and culture.

MFDS, Korea Pharmaceutical Safety Management Agency and Seoul city will hold a medical narcotics safety management training for Seoul’s monitoring officials on March 28.

Lawmaker Seo Young-seok introduced a bill to require psychiatric evaluation for inmates suspected of mental illness or self‑harm risk, noting inmate numbers have doubled since 2016.

The Korean Pharmacists Association and regional pharmacist societies staged their 343rd consecutive relay protest at the Blue House, demanding government action on licensing and duties of herbal medicine pharmacists.