Let Us Help You Navigate the Japanese Market

Japanese market entry can hold many regulatory and linguistic obstacles. As your Appointed Marketing Authorization Holder (AMAH) or MAH, we can help facilitate the PMDA process. As defined by Japan’s Ministry of Health, Labor and Welfare (MHLW), the MAH is a company in Japan that holds the marketing authorization licenses, while the AMAH handles MA holding and QC duties for a Sponsor outside of Japan. Besides, the client to become MAH in Japan can require considerable investment.

As part of CMIC’s end-to-end solutions for market entry into Japan, we provide services to help our clients to gain orphan drug designation, new drug or medical device approvals for distribution and sales in Japan tailored to their needs. For Research and Development in rare disease or intractable diseases, CMIC can support our customers on every step of the way.

Our Edge in Marketing Authorization Holding Services

Providing services for the manufacturing and sales of products in Japan

We are the only company that can propose MA Holding services to help bring your asset to Japanese patients using our innovative pharma model. We provide marketing, sales/distribution, medical affairs, pharmacovigilance, post-marketing surveillance (mandatory for new drugs in Japan), quality assurance and regulatory affairs activities.

Services

  • Support on ICCC services
  • Regulatory Affairs
  • Technology Transfer, Release testing
  • Manufacturing
  • Quality Assurance
  • Safety Management
  • Medical Affairs
  • Marketing
  • Supply Chain Management
  • Sales and Distribution
  • Post-marketing surveillance

In-Country Clinical Caretaker (ICCC)

Medical Device & IVD

Orphan Drug

Japan Market Entry