Executive Summary (FAQ)/ Key Takeaways

• What is the basic licensing structure for pharmaceutical businesses in Japan?
  Pharmaceutical regulation under Japan’s PMD Act is based on a two-layer structure: (i) business licenses, which regulate who may conduct pharmaceutical business activities and at which locations, and (ii) product licenses (marketing approvals), which regulate which pharmaceutical products may be supplied to the market.
• What is a Manufacturing and Marketing Business License (MAH license)?
  A manufacturing and marketing business license is a company-based license required for an entity that places pharmaceutical products on the market and bears ultimate responsibility for their quality, efficacy, and safety. Because this license does not include manufacturing activities, a separate manufacturing license is required when a company conducts manufacturing in-house.
• When is a manufacturing license required?
  A manufacturing license is required for each manufacturing site engaged in pharmaceutical manufacturing processes. Licenses are categorized depending on the type of manufacturing process involved (e.g., sterile products, general products, packaging/labeling/storage), and a license may be required even where only packaging, labeling, or storage activities are performed.
• What is marketing approval (product license)?
  Marketing approval is an authorization required for each individual pharmaceutical product before it may be supplied to the market. It is granted after review by the PMDA and may be transferred under certain statutory conditions.
• How do pharmaceutical licenses affect M&A and corporate restructuring?
  Unlike business licenses, product licenses may be transferred under certain conditions. However, such transfer generally requires that no changes be made to the approved product particulars. If a partial change application is required, the timing of the transfer may affect the deal structure and the closing schedule of the transaction.