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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Experts warn expanded drug delivery may strengthen private platform dominance in Korea
Policy director Jeon Jin‑han cautions that the government's plan to broaden medication delivery for telemedicine patients could increase private platform control and push medical privatization.
UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Korean Pharmaceutical Association Reviews 30 Years of Emergency Policy Committees
Over three decades, the KPA has formed emergency committees for major policy issues, noting varied outcomes influenced by political, social and public factors.
UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Korean Pharmacists Mobilize to Halt Expansion of Remote Drug Delivery
Pharmacists and civil groups in South Korea are staging protests and a nationwide rally after a petition against remote prescription drug delivery gathered 50,000 signatures.
UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
PMDA-ATC MRCT/GCP Inspection Seminar 2027 Opens Applications for APEC Regulators
The PMDA-ATC workshop in Tokyo (Jan 26‑29, 2027) offers free training on MRCT review and GCP inspection for APEC regulatory officials.
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UPDATED
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
Pharmacists Protest Expansion of Telemedicine and Drug Delivery in Seoul
Pharmacists rallied outside the Blue House, demanding a halt to the government's plan to broaden telemedicine and prescription drug delivery, urging stronger primary care and public health infrastructure.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
MFDS reviews K‑NASS system to strengthen monitoring of medical narcotics misuse
The Korean Ministry of Food and Drug Safety inspected the pilot K‑NASS system, aiming to detect misuse and illegal distribution of medical narcotics more rapidly.
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UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Pharmacists rally against government expansion of telemedicine prescription delivery
On June 13, pharmacists and allied health groups gathered in front of Seoul’s Blue House to protest the government's plan to broaden telemedicine‑based prescription drug delivery, urging a policy review.
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UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
KDCA Issues 2026‑2027 Seasonal Influenza Warning as Cases Surge in Schools
KDCA announced a 2026‑2027 influenza epidemic warning on Sep 11, citing rapid rise in cases among school‑age children and infants and urging preventive measures in group settings.
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UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Korean Pharmaceutical Association Urges Insurance Coverage for Abortion Induction Drugs
The Korean Pharmaceutical Association calls for dropping in‑hospital compounding of abortion induction drugs and pushing for health‑insurance reimbursement, warning against utilization barriers.
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UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
Relay Protest Marks 359th Day Demanding Reform of Korean Herbal Pharmacist Licensing
A relay protest in front of Seoul’s Blue House entered its 359th day, with officials urging the government and parliament to clarify and reform the licensing system for pharmacists and herbal pharmacists.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
FDA Grants Accelerated Approval for Bayer's Hyrnuo in HER2‑Mutated NSCLC
The US FDA has expanded the indication of Bayer’s oral TKI Hyrnuo, granting accelerated approval as first‑line therapy for HER2‑mutated locally advanced or metastatic non‑squamous NSCLC, based on a 75% ORR in the SOHO‑01 trial.
UPDATED
Actualizaciones regulatorias
24 sept 2026•1 min de lectura
FDA Labeling Updates for Alvogen’s Topical CICLOPIROX Gel (NDA020519)
Alvogen’s discontinued topical gel CICLOPIROX (0.77%) received FDA labeling submissions in 2013, with earlier filings dating back to 1997.