Launch Successfully in Japan with Strategic Regulatory & Market Entry Guidance

From product registration to Regulatory localization, Freyr powers your entry into Japan’s pharma market.

Need a Partner for Your Japan Launch?

Celebrating Customers Success

Your Global Partner for Local Japan Success

8+ Years of Japan Regulatory Expertise

Deep experience with PMDA processes and local compliance.

All MBL Types Secured

Demonstrating end-to-end Regulatory and operational capability.

Proven DMAH Partner

Supporting pharma and biologics clients with local representation.

Regulatory + Commercial Integration

Holistic strategies for faster, compliant market entry.

55+ Clients. One Integrated Partner.

From strategy to compliance, we cover the full Regulatory lifecycle.

Why U.S. Pharma Firms Struggle to Break into Japan

Why Choose Freyr
 

Distinct PMDA Review Structure

Requires mandatory scientific consultations, localized clinical data, and strict adherence to J-GCP, J-GMP, and GPSP-more structured than FDA protocols.

Mandatory Local MAH/DMAH

Foreign firms cannot hold product approvals directly; a Japanese MAH or DMAH is legally required to manage Regulatory, quality, and PV responsibilities.

Full Japanese Dossier Localization

Modules 1 and 2 of CTD must be submitted in Japanese; accuracy in translation is required for a high-quality dossier, which can lead to review delays.

Extended Timelines Due to Local Requirements

Bridging studies, PMDA consultations, and local quality validations often extend approval timelines beyond global launch schedules.

 
 
 

FDA vs. PMDA – Process Overview for Medicinal Products

Regulatory Step  FDA (United States)  PMDA (Japan) 
Submission Language  English  Japanese (CTD incl. Module 1&2) 
Scientific Advice  Optional Pre-IND or Type B/C meetings  Strictly recommend formal consultations (Clinical trial protocol, Pre-NDA) 
Local Clinical Data  Rarely required  Often required (or Japanese bridging studies) 
Submission Pathway  IND → NDA (or BLA for biologics)  CTN → NDA (MHLW via PMDA) 
Review Timeline (Standard NDA)  ~10 months (Priority: ~6 months)  ~12 months (Priority: ~9, SAKIGAKE: ~6) 
Accelerated Pathways  Fast Track, Breakthrough, RMAT  Priority Review, SAKIGAKE, Conditional Approval 
eCTD Requirements  Yes   Yes  
Local Legal Entity Requirement  Not mandatory  MAH or DMAH is mandatory for foreign applicants 
Pharmacovigilance Obligations  REMS if required  SMO (Safety Management Officer) of MBL Org QPPV, RMP submission, GVP/GPSP compliance 
Post-Marketing Surveillance (PMS)  Defined case-by-case  RMP, post-marketing clinical study, re-examination, etc., are mandatory 

Our End-to-End Strategy: From Planning to MHLW Approval

Step 1
Market Readiness Assessment

Evaluate your product’s alignment with Japan’s PMDA requirements to confirm regulatory readiness and eligibility.

Step 2
Regulatory Strategy & Roadmap

Define timelines, pathways, and risk mitigation plans tailored to product class and submission type.

Step 3
J-NDA / J-CTD Dossier Preparation

Compile all CTD modules or NDA documents using validated templates aligned to PMDA's expectations.

Step 4
PMDA Consultation

Facilitate clinical, non-clinical, or device consultations to refine and validate your regulatory path.

Step 5
Local Partner & FMA

Identify the right local agent and secure Foreign Manufacturer Accreditation (FMA) for compliance.

Step 6
Launch Enablement & Post-Market

Support for NHI pricing, post-approval variations, and lifecycle compliance across Japan.

Success Stories

  • Freyr Provided Comprehensive Regulatory Support Accelerating Global Submissions and Ensuring Compliance for a Japanese Pharmaceutical and Biotechnology Company Across Multiple Markets

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  • Freyr Streamlined and Standardized Submission Processes for a Japanese Drug Manufacturer's Successful Market Entry into the US Market

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  • Freyr Provided Comprehensive Regulatory Support for Managing Partial Change Applications, Renewals, and Variations for a Global Healthcare Company in China and Japan

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  • Freyr Provided Strategic Regulatory Partnership Achieving 100% On-Time Submissions and 50% Cost Savings with a Scalable Hybrid Staffing Model for a Japanese Midsize Global Pharma and Biotech Company

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Frequently Asked Questions

What is the PMDA?
The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan’s Regulatory authority responsible for reviewing drug applications, a review body of the MHLW, conducting scientific consultations, and ensuring product safety and compliance.
How does PMDA differ from the FDA?
PMDA requires Japanese CTDs, mandatory consultations, local data, and a DMAH, unlike the FDA.
What’s the typical PMDA approval timeline?
Standard review takes ~12 months; priority pathways like Sakigake can shorten it to 6–9 months.
Is a local entity required for product registration in Japan?
Yes. Foreign companies must appoint a MAH or DMAH to legally hold product approvals.
What’s the difference between MAH and DMAH?
MAH is a Japan-based holder; DMAH represents foreign firms and manages local compliance.
What is an MBL, and why is it needed?
An MBL (Marketing Business License) is required to sell or market drugs in Japan. Freyr holds all types.
What are the most common hurdles for U.S. pharma entering Japan?
  • Japanese CTD formatting
  • Translation errors
  • Lack of DMAH
  • Bridging study delays
  • Misalignment with PMDA processes
Does Freyr offer end-to-end support?
Yes, Freyr covers everything from readiness assessment to PMDA approval and post-market support.