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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

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Actualizaciones regulatorias
21 sept 2026•1 min de lectura
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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Actualizaciones regulatorias
20 sept 2026•1 min de lectura
K‑Beauty Pushes for Global Regulatory Harmonization
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.
UPDATED
Actualizaciones regulatorias
13 sept 2026•1 min de lectura
MFDS Sets 2027 Budget of 8.8 bn KRW, Emphasizes AI‑Driven Drug Approval and Global Regulatory Support
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.
UPDATED
Actualizaciones regulatorias
7 sept 2026•1 min de lectura
US Regulators Say AI-Generated Influencers Promoting Supplements Must Meet Same Truth Standards
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.
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Actualizaciones regulatorias
7 sept 2026•1 min de lectura
Korean Pharma & Bio Leaders Call for Next‑Gen Modalities, AI Integration and Regulatory Reform
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.
UPDATED
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
South Korea to Hold Public Hearing on Digital Healthcare and Health Data Law
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.
UPDATED
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
Korean Lawmaker Proposes AI Use in Local Tax Delinquency Management
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.
UPDATED
Actualizaciones regulatorias
24 ago 2026•1 min de lectura
PMDA Adds Project Team for AI Utilization Guiding Principles
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.