Regenerative Medicinal Products Act｜第 5 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
Distributors and manufacturers of regenerative medicinal products (hereinafter “Pharmaceutical Firms”) are drug dealers under Subparagraph 1, Article 15, and drug manufacturers under Paragraph 1, Article 16 of the Pharmaceutical Affairs Act. The drug manufacturers referred to in the preceding paragraph shall have a full-time, licensed pharmacist stationed at the manufacturing site to supervise the production and shall employ full-time personnel who have graduated from domestic or foreign universities or higher institutions in relevant fields such as medical or life sciences, with specialized knowledge in cytology, microbiology, or immunology, to be stationed at the site and participate in the manufacturing process.