Regulatory Updates
Sep 25, 2026•1 min read
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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Regulatory Updates
Sep 14, 2026•1 min read
KADA to Deploy 8 Doping Control Officers to Asian Games in Nagoya
KADA will send eight officials to support doping control at the Asian Games in Nagoya, Japan, from Sep 19 to Oct 4, joining a total of 44 international officers.
Regulatory Updates
Sep 8, 2026•1 min read
PMDA Requests Public Comments on Draft Regulatory Science Standards
The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.
Regulatory Updates
Sep 8, 2026•1 min read
PMDA Invites Public Comments on Draft Regulatory Science Standards
The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.
Regulatory Updates
Sep 5, 2026•1 min read
Japanese Home Medication Models Highlighted at Korean Integrated Care Conference
Yoon Sun‑hee presented Japan’s pharmacist‑led home medication systems and their relevance to Korea’s new integrated care law.
Regulatory Updates
Aug 31, 2026•2 min read
PMDA Provides Guidance and Consultation Services for SaMD Approval
PMDA outlines resources, consultations, and guidelines to support developers of software as a medical device (SaMD) in Japan.
Regulatory Updates
Aug 25, 2026•1 min read
PMDA Publishes Post‑Marketing Drug Safety Information
The PMDA and Japan's Ministry of Health, Labour and Welfare provide a webpage with drug risk information under review, noting possible translation inaccuracies and untranslated files.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Updates Japanese Pharmacopoeia with PDG Harmonized Texts
The Pharmaceuticals and Medical Devices Agency announced that PDG harmonized texts have been incorporated into updated Japanese Pharmacopoeia monographs.
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Regulatory Updates
Aug 24, 2026•1 min read
PMDA Updates ATC Learning Videos
PMDA has refreshed its ATC learning video series, providing updated educational content for pharmaceutical professionals.
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Regulatory Updates
Aug 24, 2026•1 min read
PMDA Updates Japanese Pharmacopoeia with PDG Harmonized Texts
PMDA announces incorporation of PDG harmonized texts into the Japanese Pharmacopoeia General Chapters, reflecting alignment with international standards.
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Regulatory Updates
Aug 24, 2026•1 min read
PMDA Launches New “Designation / Early Access” Website
The Pharmaceuticals and Medical Devices Agency (PMDA) announced the launch of its new “Designation / Early Access” website, providing information on early access pathways.
Regulatory Updates
Aug 24, 2026•1 min read
PMDA Launches New “Overview of Orphan Drug Designation” Website
The Pharmaceuticals and Medical Devices Agency (PMDA) has launched a new website offering an overview of Japan’s orphan drug designation process.