法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年9月22日•1 分钟阅读
Pharmacists Raise Concerns Over Expanded Prescription Home Delivery Policy in Gwangjin‑gu
The Gwangjin‑gu Pharmacists Association voiced worries to a lawmaker about the government's plan to broaden home delivery of prescription medicines, citing safety and regulatory issues.
法规动态
2026年9月22日•1 分钟阅读
MFDS Revises Standard Decoction Definition, Holds Briefing for Herbal Medicine Manufacturers
The Korean MFDS announced a meeting on Oct 10 to guide herbal medicine makers on the new standard decoction definition effective Sep 2024 and share change‑approval procedures.
法规动态
2026年9月22日•1 分钟阅读
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.
法规动态
2026年9月22日•1 分钟阅读
Lawmaker Calls for Removal of Health‑Insurance Limits on Infertility Treatment in Korea
A Korean lawmaker urged the government to lift caps on IVF and IUI coverage under national health insurance, citing patient cost barriers and the need for case‑by‑case care.
法规动态
2026年9月22日•1 分钟阅读
Korean medical groups call for stricter GLP‑1 obesity drug prescription controls
Rising GLP‑1 obesity drug prescriptions in Korea prompt calls for enhanced misuse prevention and clinical appropriateness checks.
法规动态
2026年9月22日•1 分钟阅读
Korean Pharmacy Association Calls for Public Telemedicine Platform
The Korean Pharmacy Association for Health Society urges a shift to a public, non‑profit telemedicine platform ahead of the December 24 medical law amendment.
法规动态
2026年9月22日•1 分钟阅读
KPA to Hold Seminar on Drug Identification Mark Registration for Pharma Companies
The Korean Pharmacy Information Center will host a seminar on October 22 for pharmaceutical registration staff, covering practical registration procedures and common review cases.
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法规动态
2026年9月22日•1 分钟阅读
Korean Parliament Proposes Shortening Service Period for Public Health Doctors
Bills aim to reduce the mandatory 3‑year service for public health and military assessment doctors to 2‑2.5 years, easing burden and stabilizing specialist supply.
法规动态
2026年9月22日•1 分钟阅读
Korean Pharmacists Rally 356 Days Over Han‑Yak‑Sa Licensing Issues
Pharmacists have staged a 356‑day relay rally outside the Blue House, urging resolution of confusion surrounding han‑yak‑sa licensing and a safe drug environment.
法规动态
2026年9月21日•1 分钟阅读
Korean Society of Lipid and Atherosclerosis Calls for 2‑Year Dyslipidemia Screening Interval
The society seeks to halve the national dyslipidemia screening cycle from four to two years and push for insurance and primary‑care policy updates.
法规动态
2026年9月21日•1 分钟阅读
Korean Biochem Pharm Secures Approval for Silodosin‑Rosuvastatin Combination Tablets
Korean Biochem Pharm received regulatory approval for two silodosin‑rosuvastatin sustained‑release tablets, expanding Korean United Pharm’s product line.
法规动态
2026年9月21日•1 分钟阅读
Lawmakers Propose Amendment to Medical Law to Protect Against Hospital Violence
A bill introduced by lawmaker Choi Hyuk‑jin aims to include security staff as protected persons, reduce liability for lawful restraint, and mandate security equipment, responding to over 3,300 ER disturbance reports in five years.