Regenerative Medicinal Products Act｜第 6 條｜Food and Drug Administration｜Act｜In Force
衛生福利部｜v1.0
Effective Date: 2026-01-01｜Last Amended: 2024-06-19
To manufacture or import regenerative medicinal products, pharmaceutical firms shall apply for registration and market approval with the central competent authority. The manufacturing or importation shall only take place after approval and issuance of a drug license or conditional approval. The central competent authority may grant conditional approval for the preceding item only after it has been reviewed and approved by the Regenerative Medicine Review Board. The importation of regenerative medicinal products under Paragraph 1 shall be done by the holder of a drug license or conditional approval or by their authorized representative.