Providing Services to Receive and Maintain MAH of Orphan Drugs

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 support 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.

CMIC Group Marketing Authorization Holder

Our Edge in Marketing Authorization Holder Services

Providing services for the manufacturing and sales of products in Japan

CMIC is the only CRO in Japan that can offer Marketing Authorization Holder (MAH) service as we have OrphanPacific, Inc, a pharmaceutical company with manufacturing and marketing authorization licenses, as a part of our group. We provide marketing, sales/distribution, medical affairs, pharmacovigilance, post-marketing surveillance (mandatory for new drugs in Japan), quality assurance and regulatory affairs activities.


  • 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

Medical Device & IVD


Orphan Drug

IPM Japan

Japan Market Entry

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