Expanding into the Japanese pharmaceutical market presents a wealth of opportunities for foreign companies, but it also comes with unique challenges. Regulatory complexities, language barriers, and the need for local expertise make market entry a daunting process. We have recently obtained MAH license for a licent, and would like to share our experience. In this guide, we will explore the key steps required to establish a pharmaceutical business in Japan, focusing on setting up a legal entity, obtaining an MAH (Marketing Authorization Holder) license, and leveraging regulatory consultants and CDMOs for a smoother transition.
Understanding the Japanese Pharmaceutical Market
Japan is the third-largest pharmaceutical market in the world, known for its strict regulatory framework and high demand for innovative therapies. Unlike in some other countries, pharmaceutical companies cannot directly market their products in Japan without a local legal entity or a partnership with a Japanese company. This means that companies looking to enter the market must either acquire the necessary licenses themselves or collaborate with a local partner.
On this post, we will explore the option to have your own subsidary in Japan, based on our latest experience.
1. Establishing a Legal Entity in Japan
The first step for any foreign pharmaceutical company looking to enter Japan is to establish a legal entity. While there are several structures available (e.g., KK – Kabushiki Kaisha, GK – Godo Kaisha), most companies opt for a KK due to its credibility in the market.
Challenges in Setting Up a Legal Entity
- Time-Consuming Registration Process: Setting up a KK can take a week to a few months, depending on documentation and approval times.
- Bank Account Opening Delays: Due to Japan’s strict anti-money laundering regulations, opening a corporate bank account can take quite some times, further delaying operations. 5 – 6 banks rejected our application recently !!
- Hiring Key Personnel: A pharmaceutical entity must appoint three key positions— Souseki (General Responsible), Hinseki (Quality Responsible) and Anseki (Safety Responsible).
2. Obtaining an MAH (Marketing Authorization Holder) License
A critical requirement for foreign companies is obtaining an MAH license, which allows them to hold and market drug approvals in Japan. Without this license, companies must rely on a local MAH to hold product approvals on their behalf.
Key Steps in Obtaining an MAH License
- Hiring Qualified Personnel: The company must employ qualified individuals for GQP and GVP roles. Finding talent with the necessary experience can be one of the biggest hurdles.
- Regulatory Approval Process: Companies must submit applications to the PMDA (Pharmaceuticals and Medical Devices Agency) and undergo inspections.
- Compliance with GMP Regulations: Manufacturing facilities (domestic or overseas) must comply with Japan’s Good Manufacturing Practice (GMP) standards.
3. MA Hosting as a Market Entry Strategy
For companies that want to enter the Japanese market without immediately setting up a full-fledged entity, MA hosting services offer an alternative.
- What is MA Hosting? A local partner holds the MAH license on behalf of a foreign company, allowing them to sell products in Japan without direct regulatory burdens.
- Advantages of MA Hosting: This approach reduces setup time and compliance risks while enabling faster market access.
- Our Expertise: Our company specializes in providing MA hosting services, helping foreign pharmaceutical companies navigate regulatory requirements efficiently.
Conclusion & Next Steps
Japan presents a lucrative but challenging pharmaceutical market. Foreign companies must navigate regulatory complexities, secure necessary licenses, and establish a solid business foundation. Working with experienced regulatory consultants, CDMOs, and MA hosting providers can significantly ease this process.
If your company is considering entering the Japanese pharmaceutical market, we offer expertise in MAH licensing, GQP/GVP SOPs, and regulatory compliance support. Contact us today to discuss how we can help facilitate your entry into this high-potential market.
Get in touch now to start your journey into Japan’s pharmaceutical industry!
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