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Medical Products

Review & Approval


  • To provide support to ensure the advancement of medical products with international competitiveness into global markets
  • To ensure international harmonization and advancement of specifications for medical products owing to scientific development and expanded international trade
  • To help rapid commercialization to expand therapeutic opportunities for patients with unmet medical need and encourage the local pharmaceutical industry to become a new growth engine

Key activities

  • Development of a foundation for review and approval throughout the whole lifecycle from development to use
  • Reinforced communication to protect consumers
  • Supports for product commercialization and entering into global markets
  • International cooperation to lead regulatory harmonization
  • Reinforcement of customized support through expansion of product-specific consultant, "Navigator for Commercialization of Medical Products"
  • Expansion of "Product Meeting" (a forum for communication between developers and reviewers) and continued history control
  • Providing infrastructure for various kinds of businesses (start-ups, contract research organizations, pharmaceutical companies) in various development stages
  • Strategic support to expand export of medicinal products
Development of scientific rationales for safety control policies and advanced technologies for review and assessment of medical products to protect the people
1 Advancement of policies and systems
  • Studies on the development of scientific rationales for policies and systems to ensure safety control of medical products
2 Scientific reviews and assessments
  • Studies on the development of technologies for review and assessment of the quality, safety and efficacy of medical products
3 Safe use of medical products
  • Studies to protect people using medical products
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