Regulatorische Updates

The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.

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.

Chair Kang Cheong-hee announces AI-driven reforms, electronic prescription system and telemedicine preparations to ensure Korea's health insurance financial sustainability.

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.

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.

The Ministry of Health and Welfare issued appointment orders on July 16‑17, 2026, moving senior officials in health industry policy and suicide prevention.

Lawyer Baek Seon-hee of the Justice Innovation Party submitted three bills covering national security, illegal drone flights and public welfare.

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.

Party disagreement stalls National Assembly composition, raising questions about the resumption of health‑related committees and pending legislation.

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.

The UK Medicines and Healthcare products Regulatory Agency released a list of Field Safety Notices on 1 May 2026.