Japan Regulatory Affairs Flashcards
Why is Japan an attractive market for pharmaceuticals?
It is the 3rd largest pharmaceutical market globally, has a universal health insurance system, the highest life expectancy, and regulatory reforms have reduced the historical drug lag.
What is ICH E5 and how does it affect Japan’s regulatory strategy?
ICH E5 allows extrapolation of foreign clinical data by assessing ethnic factors like metabolism and therapeutic window, enabling reduced duplication of trials in Japan.
What is ICH E17 and its impact on Japan?
ICH E17 promotes multi-regional clinical trials (MRCTs), allowing simultaneous global development and reducing regional trial duplication.
Who are the main regulatory bodies in Japan?
The Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).
What are the key responsibilities of the PMDA?
Scientific review of clinical trial applications and drug approvals, quality assessments, inspections, and engagement with expert committees.
What is required before starting a clinical trial in Japan?
Approval from both PMDA (regulatory) and Institutional Review Boards (ethics), and appointment of an In-Country Caretaker for foreign sponsors.
What is the Clinical Trial Notification (CTN) process in Japan?
Consultation with PMDA, submission of notification, 30-day silent approval unless issues arise, and lighter amendment process compared to EU.
What documents are required for a J-NDA submission?
Japanese Product Information (J-PI), Proper Use Guide, Risk Management Plan (RMP), and eCTD format with electronic datasets.
What are the accelerated approval pathways in Japan?
Priority Review, Orphan Drug Designation (ODD), and Sakigake Designation for innovative, high-priority therapies.
What are the benefits of Orphan Drug Designation in Japan?
10-year re-examination, pricing premium, tax incentives, and simplified PMDA consultations.
What is Sakigake Designation?
For pioneering drugs with novel mechanisms; offers 6-month review, extended safety monitoring, pricing premiums, and a PMDA-assigned concierge.
What are the post-marketing regulatory requirements in Japan?
Implementation of a Risk Management Plan (RMP), post-marketing studies, safety reports, and educational materials.
What are the benefits of conducting MRCTs (ICH E17) for Japan?
They align Japan’s development timelines with global markets and minimize the need for separate Japanese trials.
