Regulatorische Updates

The PMDA-ATC workshop in Tokyo (Jan 26‑29, 2027) offers free training on MRCT review and GCP inspection for APEC regulatory officials.

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.

The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.

The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.

Yoon Sun‑hee presented Japan’s pharmacist‑led home medication systems and their relevance to Korea’s new integrated care law.

PMDA outlines resources, consultations, and guidelines to support developers of software as a medical device (SaMD) in Japan.

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.

The Pharmaceuticals and Medical Devices Agency announced that PDG harmonized texts have been incorporated into updated Japanese Pharmacopoeia monographs.

PMDA has refreshed its ATC learning video series, providing updated educational content for pharmaceutical professionals.

PMDA announces incorporation of PDG harmonized texts into the Japanese Pharmacopoeia General Chapters, reflecting alignment with international standards.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced the launch of its new “Designation / Early Access” website, providing information on early access pathways.

The Pharmaceuticals and Medical Devices Agency (PMDA) has launched a new website offering an overview of Japan’s orphan drug designation process.