Series Articles of the Regenerative Medicine Dual Legislation (9) – The Final Step of Taiwan’s Regenerative Medicinal Products Act: Draft Announcement of the Regulations for Registration of Regenerative Medicinal Products

In accordance with Article 8, Paragraph 3 of the Regenerative Medicinal Products Act, on August 13, 2025, the Ministry of Health and Welfare (“MOHW”) issued a pre-announcement of the draft “Regulations for Registration of Regenerative Medicinal Products ^[1] ”, which regulates the required documents and procedures for registration inspection, transfer registration, amendment registration, and extension of medicinal product licenses for regenerative medicinal products.

I. Procedures and Requirements for Registration Inspection of Regenerative Medicinal Products

For regenerative medicinal products and products with additional approvals, product names must comply with the naming restrictions and differentiation requirements specified in the Regulations for Registration of Medicinal Products (Article 3).

Applicants for registration inspection must submit complete documents and information on the prescribed forms to the MOHW (Article 5). For products with additional approvals, the labeling, package insert, packaging content and format, and font must also comply with the requirements under Article 20 of the Regulations for Registration of Medicinal Products (Article 4).

When applying for additional approvals, pharmaceutical companies must also provide written content and explanations for the additional matters in accordance with Article 10, Paragraph 1 of the Regenerative Medicinal Products Act (Article 6). After receiving the notice of issuance for the additional approval, the registration applicant must pay the required fees and complete the documentation within three months; otherwise, the application will be denied (Article 7). As for amendment registration and transfer registration of additional approvals, the relevant provisions of the Regulations for Registration of Medicinal Products shall apply (Articles 11–12).

II. Real-World Evidence (RWE)

In addition to clinical trial reports, pharmaceutical companies may submit Real-World Evidence (RWE) as supplementary data when applying for registration inspection, to support the review of a medicinal product’s efficacy and safety. Both clinical trials and RWE may incorporate Patient-Focused Drug Development (PFDD) considerations in study design and analysis methods (Article 8).

RWE refers to results derived from Real-World Data (RWD) using appropriate analytical methods. Sources of RWD include medical records, national health insurance databases, pre- and post-marketing research data, and patient or disease registries (Article 9).
 

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[1] The public comment period is open until October 13, 2025.