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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

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UPDATED
Regulatorische Updates
21. Sept. 2026•1 Min. Lesezeit
Understanding Criminal Procedure and Evidence Admissibility in Korean Law
The article explains basic criminal procedure in Korea, noting that evidence obtained unlawfully is inadmissible and may prevent conviction without other proof.
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Regulatorische Updates
15. Sept. 2026•1 Min. Lesezeit
Korean Parliament Launches Task Force to Revise Unconstitutional Laws
The National Assembly has activated a task force to expedite amendment of 27 laws deemed unconstitutional or inconsistent with the Constitution, following directives from Speaker Jo Jeong-sik.
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Regulatorische Updates
14. Sept. 2026•1 Min. Lesezeit
Jeil Pharma Holdings Conducts Legal Training on Contracts and Fair Trade for All Subsidiary Team Leaders
Jeil Pharma Holdings provided legal education on contract practice and fair trade law to team leaders across its subsidiaries, reinforcing compliance management.
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Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Anguk Pharmaceutical Holds Company-wide Compliance Training on Fair Trade and Legal Risks
Anguk Pharmaceutical organized a company-wide compliance session, inviting lawyer Lee Jong-heon of Jipyung to discuss fair-trade and corporate governance risks across industries.
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Regulatorische Updates
4. Sept. 2026•1 Min. Lesezeit
Daewoong Bio receives 1‑month manufacturing suspension over claim handling lapse
Daewoong Bio was ordered by South Korea’s MFDS to halt production of its 300 mg Icosapent Ethyl soft capsules for one month after failing to process a consumer claim per its own standards.
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Regulatorische Updates
31. Aug. 2026•1 Min. Lesezeit
Il Dong Pharmaceutical Group Conducts Fair Trade Law Training for All Employees
Il Dong Pharmaceutical Group, with the Korea Fair Trade Mediation Agency, delivered practical fair‑trade law training to all staff on May 8, aiming to strengthen self‑compliance culture and compliance management.
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Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Pharmacies Must Report Human-Use Prescription Drug Sales to Animal Hospitals
From July 21, pharmacies are required to submit detailed reports of human-use prescription drugs sold to animal hospitals, with penalties up to 1 million KRW for non‑compliance.
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Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Pharmacist Consults on Harsh Tax Audit Result and Appeal Process
A pharmacist reports an unexpectedly severe tax audit assessment and receives advice on the taxpayer’s right to appeal and the pre‑notice review stage.
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Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Lawmakers Propose Amendments to Election Laws Amid Voting Paper Shortage
Lawmakers, including MP Baek Hye-ryeon, announced proposals to amend the Public Official Election Act and Election Commission Act to address recent voting paper shortages and election management issues.
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Regulatorische Updates
30. Aug. 2026•1 Min. Lesezeit
Korean Lawmaker Proposes AI Use in Local Tax Delinquency Management
Lawyer Seo Young-seok (Democratic Party) introduced a bill to amend the Local Tax Basic Act, allowing AI and intelligent IT for proactive tax delinquency management in Korea.
UPDATED
Regulatorische Updates
25. Aug. 2026•1 Min. Lesezeit
FDA Recall D-0296-2023 Issued Over Lack of Sterility Assurance
The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.
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Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
PMDA Posts 2026 No.2 Update
The Pharmaceuticals and Medical Devices Agency (PMDA) has posted its 2026 No.2 update, providing the latest regulatory information for stakeholders.