Review & Approval
Background
- 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
R&D
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
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- Studies on the development of scientific rationales for policies and systems to ensure safety control of medical products
- 2 Scientific reviews and assessments
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- 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
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- Studies to protect people using medical products