Are you working with cell therapy and planning a clinical trial?

An IB template for cell therapy products is now available on the Danish Medicines Agency’s website.

In addition to the Agency’s general guidance on the Investigator’s Brochure for clinical trials with ATMPs, and the template for gene therapy trials (with a minor update), a template for cell therapy products is now also available.

The documents can be found under “Special Product Areas”, within “Regulation of innovative medicinal products, including advanced therapies (ATMPs)”, under the menu item “Recommendations on the format of documentation submitted with clinical trial applications”.