Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans

Name: Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2021-06-02

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans (French, HTML) HTML
Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans (English, HTML) HTML

Related open data

Health Canada