Navigate Japan’s PMDA for Gene & Cell Therapies with Confidence

Specialized Regulatory support for ATMP, biologics, and rare disease programs in Japan.

Need Help with ATMP Regulatory Planning?

Celebrating Customers Success

Why does Freyr stand out?

99%
First-Time Right Submission Rate: Because precision matters, we deliver accuracy from the start.
99.99%
On-time delivery, every time: Stay ahead of deadlines with seamless execution and zero surprises.
0%
No Refuse-to-File errors: Complete, compliant, and submission-ready – the first time.

Strategic planning for J-NDA and ATMP submissions

Regulatory gap analysis for gene therapy dossiers

End-to-end PMDA consultation and preliminary meeting prep

Experience with SAKIGAKE and Orphan Drug pathways

Bilingual support for documents, forms, and communication

How Freyr Supports Your Japan Regulatory Journey.

Why Choose Freyr
 

PMDA strategy for gene therapy filings

Looking to bring your gene therapy to Japan? We help you align with PMDA’s evolving expectations from day one.

ATMP-specific J-NDA alignment

Have an ATMP in the pipeline? We’ll guide you through J-NDA requirements tailored to your product class.

Orphan drug pathway advisory

Wondering if your product qualifies for orphan designation? Our experts navigate the application and fast-track options with ease.

eCTD publishing and submission support

Need compliant submissions? We handle the entire eCTD lifecycle—publishing, validation, and submission to PMDA.

Manufacturing compliance (AFM, GCTP, GxP)

Struggling with local compliance? We assist with AFM coordination and ensure full GCTP and GxP adherence.

 
 
 

Why Freyr?

ATMP-specialized Regulatory consultants
Orphan & rare disease track record
Deep PMDA and APAC submission expertise
End-to-end submission support

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 qualifies as gene therapy in Regulatory terms?
Gene therapy involves the delivery of nucleic acid-based drugs to modify or manipulate the expression of a gene for therapeutic purposes.
Which Regulatory agencies oversee gene therapy in Japan?
The Ministry of Health, Labour and Welfare (MHLW) regulates gene therapy. PMDA serves as the review body for MHLW.
What is the first step toward market entry in Japan?
Engage in early PMDA consultations to align on classification, development strategy, and quality/nonclinical/clinical data expectations.
Is fast-track approval available for gene therapies?
Yes, Japan offers Conditional Early Approval and SAKIGAKE Designation for innovative gene therapy products addressing unmet needs.
What are the key challenges in gene therapy product development?
Manufacturing complexity, long-term safety data, regulatory expectations for comparability, and rare disease trial design are major hurdles.
Are bridging studies required in Japan?
Often yes, especially if initial trials were conducted outside Japan; pharmacokinetics and/or pharmacodynamic data in Japanese may be required.
How long does approval take for gene therapies in Japan?
For prioritized or conditional review pathways, approval can take approx. 9 months after complete dossier submission.
What post-market obligations exist?
Gene therapies often require long-term follow-up for safety, periodic safety reports, and real-world evidence collection.
Can foreign sponsors enter the Japanese market without a local presence?
No, an MAH (Marketing Authorization Holder) or Designated Marketing Authorization Holder (DMAH) in Japan is mandatory for market access.