規制動向
FDA、EMA、TGA および世界の規制動向
規制動向
2026年9月6日•1分で読めます
KPA Vows Strong Opposition to Gov't Full Prescription Drug Delivery Expansion
The Korean Pharmaceutical Association announced it will mount legislative and policy resistance to the government's plan to expand prescription drug delivery to all telemedicine patients, refusing to join related government talks.
規制動向
2026年9月6日•1分で読めます
Korea Fair Trade Commission refunds over 100 bn KRW in fines despite 90% win‑rate claim
KFTC reports net fine refunds exceeding 106 bn KRW in seven months, highlighting a gap between its claimed 90% administrative‑lawsuit win rate and court rejections of fine calculations.
規制動向
2026年9月6日•1分で読めます
Lawmaker Proposes National Suicide Prevention Fund; PM Signals Support
Lawmaker Kim Gyo‑heung called for a life‑cycle suicide‑prevention system and a National Suicide Prevention Fund, noting budget gaps. The Prime Minister agreed to examine the proposal closely.
規制動向
2026年9月6日•1分で読めます
Korea urges multidisciplinary inpatient care with dedicated pharmacists
Health professionals and the government in Korea call for formalizing multidisciplinary team care for hospitalized patients, including ward‑dedicated pharmacists, with staffing and compensation standards.
規制動向
2026年9月6日•1分で読めます
Health Insurance Premium Relief and Extra Benefits for Disaster‑Hit Residents in Gyeongbuk and Gyeongnam
Korea Health Insurance Corp announced reduced premiums and additional coverage for lost dentures and disability aids for residents of newly declared special disaster zones.
規制動向
2026年9月6日•1分で読めます
UK Enacts Tobacco and Vapes Act 2026 to Protect Future Non‑Smoking Generation
The National Assembly Library announced a briefing on the UK’s Tobacco and Vapes Act 2026, aimed at preventing youth smoking and closing regulatory gaps for e‑cigarettes and nicotine pouches.
規制動向
2026年9月6日•1分で読めます
South Korean Health NGOs Criticize Government's Telemedicine Drug Delivery Expansion
Civil society health groups in South Korea denounced the Lee Jae‑myung administration’s plan to fully expand telemedicine drug delivery, urging investment in public medical infrastructure instead.
規制動向
2026年9月6日•1分で読めます
HuBase Hosts 2026 Pharmacy Opening Symposium on Risk Management in Seoul
HuBase co‑hosted a symposium in Seoul on May 23, offering practical criteria to assess pharmacy property values and contracts amid growing market complexity.
規制動向
2026年9月6日•1分で読めます
EMA PRAC launches review of injectable iron medicines over hypophosphatemia risk
The EMA's Pharmacovigilance Risk Assessment Committee has started a review of injectable iron products concerning low blood phosphate levels and related bone problems.
規制動向
2026年9月6日•1分で読めます
Korea to expand telemedicine prescription delivery, faces hurdles
The Korean government proposes broader prescription delivery for telemedicine patients, but experts question the evidence and note needed legal changes.
規制動向
2026年9月6日•1分で読めます
TDS Farm fined 19.35 million KRW for record‑keeping violations in Kataplasmaze contract manufacturing
South Korea's MFDS fined TDS Farm 19.35 million KRW, replacing a 15‑day production halt for the Kataplasmaze formulation after finding missing concurrent manufacturing records.
規制動向
2026年9月6日•1分で読めます
Korean Pharmacies Gain Regulatory Boost for Custom Health Foods
Regulatory updates exempt pharmacies from business registration and provide a checklist, allowing pharmacy managers to act as product managers and outsource splitting without dedicated facilities.