Regulatory Updates
Sep 22, 2026•1 min read
FDA Issues Tentative Approval for Atomoxetine Hydrochloride Capsules (ANDA078940)
The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.
Regulatory Updates
Sep 21, 2026•1 min read
Parliamentary Forum Addresses Operating‑Room CCTV Reform on 10th Anniversary of Kwon Dae‑hee Death
Lawmakers and health NGOs held a discussion on improving operating‑room CCTV to protect patient rights, marking ten years since Kwon Dae‑hee’s death.
Regulatory Updates
Sep 21, 2026•1 min read
Health Insurance Chair Outlines AI, Telemedicine & Sustainability Plans
Chair Kang Cheong-hee announces AI-driven reforms, electronic prescription system and telemedicine preparations to ensure Korea's health insurance financial sustainability.
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Regulatory Updates
Sep 18, 2026•1 min read
South Korea's President outlines two-year plan for abortion pill prescription and dispensing
President Lee Jae‑myung indicated that abortion medication could be prescribed and dispensed in‑hospital for two years, then shift to hospital prescription with external pharmacy dispensing.
Regulatory Updates
Sep 14, 2026•1 min read
South Korea Health and Welfare Committee Schedules Bill Review Subcommittee Meetings for Oct 15‑16
The National Assembly Health and Welfare Committee will hold subcommittee sessions on Oct 15 and 16 to examine health‑related legislation, following a plenary meeting on Oct 11.
Regulatory Updates
Sep 4, 2026•1 min read
South Korea Health Ministry Announces Director‑Level and Manager‑Level Personnel Transfers
The Ministry of Health and Welfare issued appointment orders on July 16‑17, 2026, moving senior officials in health industry policy and suicide prevention.
Regulatory Updates
Sep 4, 2026•1 min read
South Korean Lawmaker Introduces Three Bills on Future Security and Public Welfare
Lawyer Baek Seon-hee of the Justice Innovation Party submitted three bills covering national security, illegal drone flights and public welfare.
Regulatory Updates
Sep 2, 2026•1 min read
Celltrion Maintains AAA AEO Certification for Export and Import
Celltrion renewed its AAA‑level AEO certification for both export and import, remaining the only pharma company in Korea with the top customs compliance rating.
Regulatory Updates
Aug 30, 2026•1 min read
Parliamentary Stalemate Hinders Health Committee Activities in South Korea
Party disagreement stalls National Assembly composition, raising questions about the resumption of health‑related committees and pending legislation.
Regulatory Updates
Aug 30, 2026•1 min read
Daewoong Pharmaceutical Initiates Phase 1 Trials of Olmesartan‑Indapamide Triple Antihypertensive
Daewoong Pharma received MFDS approval for two Phase 1 studies of its olmesartan‑amlodipine‑indapamide combo (DWJ1622), assessing PK and safety in fasting (44) and fed (36) healthy adults.
Regulatory Updates
Aug 23, 2026•1 min read
MHRA Publishes Field Safety Notices on 1 May 2026
The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices on 1 May 2026.