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FDA, EMA, TGA and global regulatory developments

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Regulatory Updates
Sep 21, 2026•1 min read
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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Regulatory Updates
Sep 15, 2026•1 min read
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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Regulatory Updates
Sep 14, 2026•1 min read
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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Regulatory Updates
Sep 4, 2026•1 min read
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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Regulatory Updates
Sep 4, 2026•1 min read
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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Regulatory Updates
Aug 31, 2026•1 min read
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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Regulatory Updates
Aug 30, 2026•1 min read
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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Regulatory Updates
Aug 30, 2026•1 min read
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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Regulatory Updates
Aug 30, 2026•1 min read
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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Regulatory Updates
Aug 30, 2026•1 min read
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.
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Regulatory Updates
Aug 25, 2026•1 min read
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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Regulatory Updates
Aug 23, 2026•1 min read
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.