Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Daewoong Pharma dispute over block‑type hub wholesale escalates
Conflict over Daewoong Pharmaceutical’s block‑type hub wholesale is set to intensify after the Fair Trade Commission dismissed the Korean Pharmaceutical Distribution Association’s complaint, prompting a planned re‑submission and a push for a parliamentary audit.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
2027 78th Pharmacist National Exam Registration Opens in Korea
The Korea Health Personnel Licensing Examination Institute announced the opening of applications for the 78th pharmacist national exam in 2027, noting minor procedural updates and changes to cancellation and fee refund policies.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Stryker LP35 Defibrillator Display Issue Identified
Stryker reports the LP35 may not display the "CHECK RHYTHM / ECG Analysis Inconclusive" message under certain conditions, while shock advisories and therapy remain functional.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Korean Pharmacy Association Supports Fast Abortion Drug Introduction
The Korean Health Society Pharmacy Association (건약) praised President Lee Jae‑myung’s call to swiftly introduce abortion medication and urged the government to accelerate approval processes.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Stryker LP35 Defibrillator Fails to Show “Check Rhythm” Prompt
Health Canada reports Stryker’s LP35 may not display the “CHECK RHYTHM / ECG Analysis Inconclusive” message, though shock advisories and therapy remain unaffected.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Olympus Issues Recall of BiCOAG Hemostasis Probe Over Adhesive Defect
Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to potential ceramic tip detachment.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Olympus Recalls BiCOAG Hemostasis Probe Over Adhesive Defect
Olympus advises immediate discontinuation of BiCOAG Hemostasis Probe due to possible adhesive shortage causing ceramic tip detachment.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Progen Begins High‑Dose Phase 1 Trial of PG‑102 for Obesity
Progen has received MFDS approval to start a high‑dose Phase 1 study of its obesity/diabetes candidate PG‑102, assessing safety, tolerability and PK/PD at Seoul St. Mary’s Hospital.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Fair Trade Commission Closes Daewoong Pharma Wholesale Complaint
The Fair Trade Commission has closed the Korea Pharmaceutical Distribution Association’s complaint regarding Daewoong Pharmaceutical’s regional wholesale, without providing specific reasons.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
BioSolution Begins Domestic Clinical Development of SperoQure Injectable OA Cell Therapy
BioSolution received MFDS approval for the IND of its injectable osteoarthritis cell therapy, SperoQure, and will commence Phase 1/2a trials to assess its DMOAD potential.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Blood Contamination Risk in Quantum PureFlow Heat Exchanger
Health Canada reports blood-to-glycol leakage in the Quantum PureFlow heat exchanger, prompting advisories to users about possible heater‑cooler contamination.
Regulatorische Updates
2. Sept. 2026•1 Min. Lesezeit
Potential Blood Contamination Risk Identified in Quantum PureFlow Heat Exchanger
Blood-to-glycol leakage in the Quantum PureFlow heat exchanger may lead to blood contamination of heater‑coolers; users should be notified.