Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
PMDA-ATC MRCT/GCP Inspection Seminar 2027 Opens Applications for APEC Regulators
The PMDA-ATC workshop in Tokyo (Jan 26‑29, 2027) offers free training on MRCT review and GCP inspection for APEC regulatory officials.
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Regulatorische Updates
16. Sept. 2026•1 Min. Lesezeit
MFDS Identifies GCP Gaps in Dayvigofilm Coating Tablet (Rembolexant) Approval Process
The Korean MFDS flagged protocol adherence, monitoring and record‑keeping issues in the clinical trial for Dayvigofilm coating tablet, though no serious violations were found.
Regulatorische Updates
23. Aug. 2026•1 Min. Lesezeit
PMDA Posts Report from Asia Office GCP Workshop 2026
The Pharmaceuticals and Medical Devices Agency has posted the report from its 2026 Asia office GCP workshop.