Having been approved as an official Marketing Authorization Holder (MAH), IDA is able to file and maintain official submissions to MHLW on behalf of IDA clients.

As an MAH, IDA is able to officially undertake the following responsibilities for clients:

  • Filing and maintaining Japanese New Drug Applications (J-NDA)
  • Filing and maintaining Orphan Drug Designation Applications (ODD)
  • Submit applications for and receive subsidies from National Institute for Biotechnology Innovation (NIBIO)
  • Conduct GMP audits at local and overseas manufacturing sites
  • Obtain approval and maintain of National Health Insurance (NHI) drug pricing
  • Management of mandatory Post-Marketing Surveillance (PMS) programs
  • Manage product lifecycle, including obtaining approvals for new indications
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