Guidance on Investigator Brochure Content for ATMP Clinical Trials
Summary
The Danish Medicines Agency has published guidance on the required content of the Investigator's Brochure for clinical trials involving Advanced Therapy Medicinal Products (ATMPs). The guidance integrates the ICH GCP IB format description with ATMP-specific recommendations from the EMA guideline on ATMPs in clinical trials. Sponsors and clinical investigators conducting ATMP trials should review the guidance and ensure their Investigator's Brochures align with these requirements.
“The Danish Medicines Agency has prepared guidance specifically aimed at clinical trials involving advanced therapy medicinal products (ATMPs).”
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What changed
The Danish Medicines Agency published guidance specifying the required content of the Investigator's Brochure for clinical trials involving Advanced Therapy Medicinal Products. The guidance builds on the ICH GCP IB format description combined with ATMP-specific recommendations from the EMA guideline.\n\nAffected parties—sponsors, clinical investigators, and contract research organizations conducting ATMP trials in Denmark—should review this guidance and update their Investigator's Brochure templates and existing documentation to ensure compliance with the specified content requirements.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
News / 2026 / For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
For Clinical Trials with ATMP: Guidance to the content of the Investigator´s Brochure published
06 March 2026
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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”
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