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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Korean Pharmacists Hold 355th Day Relay Protest at Blue House Over Herbal Licensing
The Korean Pharmacists Association marked the 355th consecutive day of a relay rally in front of the Blue House, urging the government to address licensing issues affecting herbal medicine pharmacists.
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UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
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.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
KPA Committee Plans Response to Expanded Telemedicine Drug Delivery
The KPA’s Emergency Committee held its first operating and execution meetings to plan actions against the government’s push to broaden prescription drug delivery for telemedicine.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
FDA Grants Accelerated Approval to AstraZeneca’s Oral SERD Etcamah for HR‑Positive/HER2‑Negative Breast Cancer
The US FDA approved AstraZeneca’s oral SERD camizestrant, branded Etcamah, for HR‑positive/HER2‑negative breast cancer patients with ESR1‑mutated ctDNA detected before radiographic progression, based on the Phase 3 SERENA‑6 trial.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Patient groups urge reform of diabetes device reimbursement as CGM and insulin pump coverage expands
With coverage extending to severe type‑2 diabetes, groups call for a shift from upfront payment to direct co‑payment at pharmacies for CGM and insulin pump devices.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Parliamentary Government Q&A Session May Address Pharmacist Issues
Lawmakers begin a series of government‑question sessions, with pharmacist concerns under watch as the agenda runs through Aug 14.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
MFDS eases safety data burden for medical gases and expands orphan‑drug ingredient specs
MFDS announced partial amendments to drug approval regulations, reducing documentation for medical high‑pressure gases and widening multiple‑specification allowances for orphan‑drug active ingredients.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
South Korean Health Authorities Audit Paxlovid Stock as COVID-19 Cases Rise
Health officials are checking pharmacy inventories of Paxlovid and pharmacies are securing more supplies, while interest revives in IlDong Pharma's oral antiviral candidate.
UPDATED
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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UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Korean Pharmacists Mobilize Against Expanded Telemedicine Prescription Delivery
The Korean Pharmaceutical Association has launched an emergency committee and announced protests on March 13 and 20 to oppose the government's plan to broaden delivery of prescription drugs for telemedicine.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Kor-GLASS Marks 10 Years with National Antimicrobial Resistance Surveillance Symposium
The Korea Disease Control and Prevention Agency held a symposium in Cheongju to review ten years of Kor-GLASS data and discuss future directions for national AMR response.
UPDATED
Actualizaciones regulatorias
21 sept 2026•1 min de lectura
Korea to Lower Colon Cancer Screening Age to 45 and Shift to Colonoscopy by 2028
Repeated blood in stool warrants testing; Korea will lower screening age from 50 to 45 and replace fecal tests with colonoscopy starting 2028.