規制動向

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

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.

South Korea’s MFDS announced a 2027 budget of 8.829 billion KRW, focusing on AI‑based drug approval, global regulatory assistance, and a state‑run stockpile for essential medicines.

A New York Times probe found hundreds of AI‑created virtual health personas promoting dietary supplements on social media, prompting US ad regulators to apply existing truth‑in‑advertising rules to AI spokespeople.

At CPHI Korea 2026, experts urged Korean pharma and biotech firms to secure next‑generation modalities, fuse physical AI, and expedite preclinical and data legislation updates.

South Korea's Ministry of Health and Welfare announced a public hearing on the proposed Digital Healthcare and Health Information Utilization Support Act, inviting experts and the public to discuss key issues.

Lawyer Seo Young-seok (Democratic Party) introduced a bill to amend the Local Tax Basic Act, allowing AI and intelligent IT for proactive tax delinquency management in Korea.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced a new project team to develop guiding principles for AI utilization, listed under its “Projects Across Multi‑Offices” initiative.