For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published

See the Danish Medicines Agency’s guidance on the content of the Investigator’s Brochure for clinical trials with ATMPs.

The Danish Medicines Agency has prepared guidance specifically aimed at clinical trials involving advanced therapy medicinal products (ATMPs). The guidance describes the required content of the Investigator’s Brochure (IB).

The guidance is based on the ICH GCP description of the IB format, combined with the ATMP‑specific recommendations from the EMA guideline on ATMPs in clinical trials.

The guidance can be found on the Danish Medicines Agency’s webpage on the regulation of innovative medicinal products, including ATMPs, under the section:

“Guidance on the format of documentation submitted with the clinical trial application”