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Japan is one of the most attractive and lucrative pharmaceutical markets in the world—but it is also one of the most tightly regulated. For foreign manufacturers, one regulatory requirement stands above all others: local agent representation. Without it, product registration in Japan is simply not possible.
The MAH/DMAH Requirement Explained
In Japan, medicinal products cannot be registered, imported, or sold unless a locally established entity holds regulatory responsibility. This role is fulfilled by either a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH).
The MAH/DMAH is legally accountable for:
- Product quality, safety, and efficacy
- Post-marketing surveillance
- Regulatory compliance throughout the product lifecycle
- Communication with Japanese health authorities
Without this local presence, applications are automatically rejected—regardless of how strong the scientific data may be.
Why Foreign Manufacturers Face Rejections
Many global companies underestimate the complexity of Japan’s regulatory framework. Common pitfalls include:
- No legally established MAH/DMAH in Japan
- Incomplete or non-localized dossiers
- Misalignment with Japanese guidelines and expectations
- Communication gaps with authorities like the Pharmaceuticals and Medical Devices Agency (PMDA)
These issues often result in costly delays, multiple review cycles, or outright rejections.
How Freyr Simplifies Japan Market Entry
At Freyr Solutions, we eliminate these challenges by acting as your trusted local partner in Japan.
Our Japan-focused regulatory services include:
- MAH/DMAH Representation
We act as your legally compliant local authorization holder, ensuring uninterrupted market access. - Compliant Dossier Preparation
Our experts prepare and localize CTD dossiers aligned with Japanese regulatory requirements and PMDA expectations. - Strategic Regulatory Guidance
From early development strategy to approval and lifecycle management, we help you make informed, risk-mitigated decisions. - Authority Liaison
We manage all communication with Japanese authorities, including consultations, responses to queries, and post-approval commitments.
Beyond Japan: A Global Regulatory Advantage
While MAH/DMAH services are critical for Japan, Freyr goes beyond local representation. We offer end-to-end Global Regulatory solutions, supporting submissions across 120+ countries with a team of 2,400+ regulatory professionals.
This integrated approach allows sponsors to:
- Maintain consistency across global filings
- Reduce duplication of effort
- Accelerate approvals across multiple markets
- Ensure long-term compliance worldwide
The Bottom Line
Japan’s regulatory system rewards preparation, precision, and local expertise. Without MAH or DMAH representation, even the most promising products cannot enter the market. With the right partner, however, Japan becomes not a barrier—but a strategic opportunity.
Let Freyr simplify your Japan submissions, avoid rejections, and accelerate your path to market.Contact us to learn how our MAH/DMAH and global regulatory services can support your success.
