Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Korean Pharmacists Demand Clarification of Scope Between Pharmacists and Herbal Pharmacists
Pharmacist groups have held relay rallies for 350 days, urging the government to define licensing duties and tighten drug‑handling rules.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
South Korea Health and Welfare Committee Schedules Bill Review Subcommittee Meetings for Oct 15‑16
The National Assembly Health and Welfare Committee will hold subcommittee sessions on Oct 15 and 16 to examine health‑related legislation, following a plenary meeting on Oct 11.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Suwon Court Rules Hospital Closure Determined by End of Medical Services for Pharmacy Goodwill Refund
The Suwon District Court held that a hospital is considered closed when medical services and prescription issuance cease, affecting goodwill return clauses in pharmacy transfer agreements.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Takeda's Orexin Agonist Orzeyful Receives FDA Approval, Targets Narcolepsy and Beyond
Takeda secured FDA clearance for Orzeyful, the first orexin‑based therapy for type‑1 narcolepsy, and experts see potential expansion into arousal, cognition and fatigue treatments.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
White House Releases Second MFN Drug Pricing Negotiation Results for Mid‑Size Pharma
The White House disclosed the second round of MFN drug‑price negotiations, now focusing on mid‑size pharmaceutical and biotech firms such as Alcon, Astellas and Teva.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
KPA Calls for Immediate Resolution of Long‑standing Herbal Pharmacist Licensing Issues
The Korean Pharmacists Association held its 349th day rally, urging the government and parliament to clarify pharmacist and herbal pharmacist license scopes and resolve the issue promptly.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Health and Welfare Committee Subcommittee to Review Pharmacist Law Amendments Mid-Month
The Health and Welfare Committee’s bill review subcommittee is expected to meet in mid‑month to consider pending pharmacist‑related legislation, including amendments to the pharmacist law.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Onnuri Responds to Pharmacist Societies' Inquiry on Mega Onnuri Pharmacy Model
Onnuri clarified that Mega Onnuri pharmacies operate under an independent pharmacist franchise model, detailing the head office’s role and sub‑lease structure after regional societies raised concerns.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Severe Drug Reactions Eligible for Compensation per MFDS Review Committee
MFDS confirms compensation for patients with Stevens‑Johnson syndrome, anaphylactic shock and Dress syndrome after specific drug use.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
South Korea Establishes Regional Essential Public Healthcare Office, Names Son Young‑rae Director
South Korea's Ministry of Health and Welfare creates a new office to integrate regional, essential and public healthcare, with its first director pledging collaborative action to close medical gaps.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
KPA Sets Name and Structure of Committee to Block Convenience Store Drugs and Telemedicine Delivery
The Korean Pharmaceutical Association confirmed the official name and detailed organization of an emergency response committee aimed at preventing the expansion of convenience‑store drug sales and telemedicine drug delivery.
Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
South Korea Introduces New Designation for Semi‑Innovative Pharma Firms with R&D‑Based Price Benefits
Korea's Ministry of Health and Welfare unveils a designation system granting generic price incentives to semi‑innovative pharma companies that meet R&D investment thresholds, excluding violations older than five years.