Overview
Japan is the world's third-largest pharmaceutical market but has unique regulatory hurdles. We support your interactions with the PMDA, helping you design bridging strategies to use foreign clinical data and manage the formal consultation process required for approval.
Key Features
Clinical data bridging strategy
PMDA consultation management
Sakigake designation support
Orphan drug applications in Japan
Our Process
1
Assessment
Evaluating the applicability of foreign data (ICH E5).
2
Consultation
Formal meetings with PMDA to agree on the data package.
3
J-NDA
Supporting the Japanese New Drug Application.
Project Complete & Deliverables Provided
Frequently Asked Questions
ICH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data) is a guideline that allows Japan to accept foreign clinical data if ethnic factors won't affect safety or efficacy. It defines 'intrinsic' factors (genetics, body weight) and 'extrinsic' factors (diet, medical practice). Before E5 (1998), Japan often required complete local clinical programs. Now, bridging studies can demonstrate applicability of foreign data.
Why Choose Us
- Access to a major global market
- Reduced need for local trials
- Clear regulatory path
- Cultural and scientific alignment
Get More Details
Request a personalized consultation and detailed information about this service.
Personalized consultation
Detailed service information
Custom timeline & proposal
We'll respond within 24 hours
Ready to get started?
Contact our team to discuss your specific needs for PMDA (Japan) Consultations.
Schedule ConsultationWhat Our Clients Say
"PMDA initially requested a full bridging study. Adelphi helped us make the case that our global MRCT with 15% Japanese enrollment was sufficient. The PMDA consultation went smoothly, and we received approval 3 months after FDA."
Dr. Kenji Yamamoto
Global Development Lead
Pharmaceutical Company
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