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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

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UPDATED
Actualizaciones regulatorias
22 sept 2026•1 min de lectura
MFDS Revises Digital Therapeutic Device Clinical Trial Guidelines for 7 Indications
South Korea's MFDS has detailed new review criteria and updated guidelines for digital therapeutic device trials covering seven mental‑health and substance‑use disorders.
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.