##  [What is MAH vs DMAH?](/what-is-mah-vs-dmah) 

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In Japan, MAH (Marketing Authorization Holder) and DMAH (Designated Marketing Authorization Holder) are critical regulatory roles that determine who is legally responsible for a pharmaceutical product in the market.

Under the Pharmaceuticals and Medical Devices Act (PMD Act), no medicinal product can be marketed, imported, or sold in Japan without a locally established MAH or DMAH.

## What is the Difference Between MAH and DMAH?

While both roles hold regulatory responsibility, their scope differs:

- MAH (Marketing Authorization Holder)  
    A Japan-based company that holds the product license and takes full regulatory and commercial responsibility
- DMAH (Designated MAH)  
    A Japan-based entity designated by a foreign manufacturer to act as the local license holder on their behalf

**In simple terms:**  
MAH = Local company owns and manages the product  
DMAH = Local representative for foreign manufacturers

## What Are Their Key Responsibilities?

Both MAH and DMAH are legally accountable for:

- Product quality, safety, and efficacy
- Compliance across the product lifecycle
- Post-marketing surveillance (PMS)
- Pharmacovigilance (GVP compliance)
- Communication with PMDA and MHLW
- Product recalls, if required

**When Do You Need MAH vs DMAH?**

- MAH → Used by companies with an established legal presence in Japan
- DMAH → Required for foreign manufacturers without a Japanese entity

Without one of these, market entry in Japan is not possible.

## Why This Distinction Matters

Choosing between MAH and DMAH is not just a regulatory step—it’s a strategic decision.

It impacts:

- Speed of market entry
- Control over product lifecycle
- Compliance risk and accountability
- Long-term commercialization strategy in Japan

Incorrect structuring can lead to **approval delays, compliance issues, or operational inefficiencies**.

**The Bottom Line**

MAH and DMAH form the foundation of Japan’s regulatory framework.

- For global companies, DMAH enables market access.
- For local companies, MAH ensures full control and responsibility.

Understanding the difference is essential to enter, operate, and scale successfully in Japan.