What we learned by doing it ourselves — and why it’s only possible with local expertise
“We Thought It Would Be Impossible. It Wasn’t — But Only Because We Knew the Terrain.”
When we set out to establish a fully licensed MAH (Marketing Authorization Holder) in Japan — from scratch — we expected bureaucracy, language barriers, and months of regulatory fog. And yes, those things came. But they weren’t what stopped us.
The real challenges were more subtle. They were rooted in local administrative culture, undocumented expectations, and small procedural details that don’t appear in English-language guidelines or PMDA documentation.
And yet — we did it. In six months, starting with just a joint venture agreement with a German pharmaceutical partner, we successfully:
- Incorporated a legal entity
- Recruited the three critical GQP/GVP roles (the “San’yaku”)
- Built and implemented a compliant QMS
- Navigated prefectural regulatory approvals
- And received full MAH authorization from the Kanagawa authorities
Here are five things we learned the hard way — and why, even though it’s hard, it’s also surprisingly achievable if you have the right local knowledge.
1. GQP/GVP System Setup Sounds Scary — But It’s Surprisingly DIY
Hard Truth: Setting up a full QMS involves over 30 SOPs, which can feel overwhelming.
But Manageable If: You leverage public model SOPs provided by Tokyo and Osaka prefectures.
When we first looked at the number of SOPs required under GQP and GVP guidelines — for quality control, safety management, documentation, change control, supplier management, and more — the task felt enormous.
But here’s the good news: you don’t have to write them from scratch.
Both the Tokyo Metropolitan Government and Osaka Prefecture publish complete, compliant SOP templates on their websites — for free.
We downloaded the model SOPs and customized them to reflect our actual workflows. Yes, it took time. Yes, maintaining consistency across documents required attention. But from a technical standpoint, any serious company can do this in-house without paying a consultant.
🛠️ Tip: Use the model SOPs as your backbone. Focus your effort on aligning them with your actual business processes — not reinventing the format.
2. Opening a Bank Account as a Foreign-Owned Entity
Hard Truth: Foreign UBO = Long delays, even with a Japanese representative.
But Manageable If: You leverage JETRO and know which banks are open to SMEs.
Opening a bank account was arguably the most frustrating part of the entire process — not because it was complex, but because it was opaque.
Even though our JV had a Japanese representative director, the fact that the ultimate beneficial owner (UBO) was a foreign company triggered anti–money laundering red flags. Online banks flatly rejected us. Several major banks declined without clear reasons. In Japan’s tightening financial regulatory environment, this is becoming the norm — especially for pharmaceutical companies.
What finally worked? A personal introduction through JETRO (Japan External Trade Organization) to Mizuho Bank, which had internal protocols for foreign JV structures. Without that, we might still be waiting.
🔎 Takeaway: If your company is foreign-owned, budget 3–5 months for account setup, and don’t assume “having a Japanese rep” is enough. Relationships matter more than forms.
3. Hiring the “San’yaku” – Easier Than Expected (If You Speak Japanese)
Hard Truth: The market is tight; talent is scarce.
But Manageable If: You remove the English requirement and use local networks.
Hiring the required personnel — General Manager (Sōkatsu), Quality Manager (Hinseki), and Safety Manager (Ansei) — is where most foreign companies get stuck. Japan’s pharmaceutical talent pool is limited, and bilingual professionals with direct MAH experience are even rarer.
But in our case, the process was surprisingly smooth — because we:
- Used existing local networks (no recruiter needed)
- Dropped the English requirement and handled bilingual communication ourselves
- Hired a senior-level General Manager, and filled the other two roles with mid-level professionals who met the legal minimums
Also worth noting: In Germany or France, hiring takes time due to 3-month notice periods. In Japan, most professionals can leave within 1 month, making rapid onboarding possible.
However — be aware that Japan does not permit remote, freelance, or part-time San’yaku for MAH license purposes. We confirmed this directly with Kanagawa’s Yakumuka. Direct employment and on-site presence are required.
💡 Pro Tip: If you can bridge the language gap internally, your hiring flexibility improves dramatically.
4. Navigating Prefectural Licensing — Not All Regions Are Equal
Hard Truth: There is no one Japan — every prefecture is different.
But Manageable If: You contact Yakumuka early and build local rapport.
One of the least understood aspects of Japan’s pharmaceutical regulation system is that marketing authorization is administered at the prefectural level — not by a centralized agency like the PMDA. This means that timelines, expectations, and even documentation nuances can vary depending on where your company is based.
In our case, we dealt with the Kanagawa Prefecture Pharmaceutical Affairs Division (Yakumuka). While Tokyo, for example, offers online reservation systems and more fluid communication, Kanagawa required advance appointments for every step of the process, sometimes with several weeks of lead time. If you wait until all your documents (SOPs, San’yaku contracts, etc.) are ready before reaching out, you’ve already lost valuable time.
What we learned:
- Book a pre-consultation appointment early — even if your internal systems aren’t finalized
- Use the waiting period to fine-tune your QMS and documents
- Understand that each Yakumuka has its own way of interpreting national standards
🗾 Reminder: Japan is a country of administrative micro-climates. What works in Osaka may not apply in Kanagawa or Fukuoka.
5. Incorporation Strategy Matters More Than You Think
Hard Truth: Foreign UBO adds documentation complexity.
But Manageable If: You consider a two-step structure (Japanese setup → equity transfer).
One thing we realized — too late — is that Japan treats foreign-owned entities with a different level of scrutiny during incorporation and financial onboarding. Even with a Japanese representative director, the fact that the ultimate owner is a non-Japanese entity means additional paperwork, verification procedures, and delays, especially when it comes to opening a bank account.
Had we done it again, we might have:
- First incorporated the company with 100% Japanese shareholders and officers (temporarily)
- Secured the bank account and licenses
- And then transferred shares to the foreign parent company after setup
This phased approach could have saved us months. However, it comes with one caveat: some banks may view post-hoc equity transfers as suspicious, especially if they weren’t disclosed upfront.
⚖️ Cautionary Note: This strategy isn’t about “hiding ownership,” but about reducing setup friction. If you go this route, consult legal and financial advisors to ensure full transparency.
Final Thoughts: You Probably Can’t Do It Alone — But That’s Okay
Yes — we built a licensed MAH in Japan from scratch.
Yes — it was doable, even without hiring a consulting firm.
But here’s the truth: if you’re not already in Japan, and you don’t speak the language or understand the local ecosystem, this process is not realistically repeatable.
Everything from hiring the right San’yaku, to building trust with regulators, to knowing which prefectures allow what — requires local insight, cultural literacy, and existing networks.
That’s why we founded WeBD.Tokyo — not as a consulting firm, but as a local partner who’s already walked this path.
If your company is serious about launching in Japan — whether you’re a CDMO, specialty pharma, or clinical-stage innovator — we’d be happy to share what we’ve learned (and help you avoid what we’ve suffered).
📩 Ready to talk?
Let’s explore what your MAH strategy could look like — the real way, not the brochure version.