Taiwan Food and Drug Administration announced the publication of the “Guidelines for Clinical Trial Applications of Human Extracellular Preparations.”

The announcement was issued on April 29, 2026, under approval number FDA Drug Approval No. 1151403418.

Purpose of the Guidelines

The guidelines are intended to support developers of extracellular formulations in preparing applications for domestic clinical trials.

They provide structured guidance for submission requirements related to these products.

Availability

The guidelines are published as an official attachment and are also accessible through the “Announcements and Information” section on the agency’s website. http://www.fda.gov.tw/

Supporting Documents and Appendices

The announcement includes several supporting documents related to clinical trial applications for human extracellular vesicle formulations, including:

• FDA drug approval number 1151403418 issued on April 29, 2015.
• Guidelines for Clinical Trial Applications of Human Extracellular Preparations (including attachments)
• Appendix 4: Checklist of Required Documents for Clinical Trial Application of Human Extracellular Vesicle Formulations (WORD file)
• Appendix 5: Summary Table of Clinical Trial Plan for Human Extracellular Vesicle Therapy (WORD File)
• Appendix 6: Application Form for Access to Clinical Trial Reports of Human Extracellular Vesicle Formulations (WORD File)
• Appendix 7: List of Testing Institutions (WORD file)

Regulatory Scope

The guidance applies to clinical trial applications involving human extracellular preparations, including extracellular vesicle-based formulations.

For more information: Announcement "Guidelines for Clinical Trial Applications of Human Extracellular Preparations"

Supporting Regulatory Processes

New clinical trial guidelines and documentation requirements can directly impact submission preparation and regulatory strategy for advanced therapies.

Baupharma’s Regulatory Affairs services support companies with clinical trial applications, dossier preparation, and alignment with evolving regulatory requirements:
https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services