Non-clinical regulatory advice

CTCG has published a new recommendation paper on principles of Good Laboratory Practices (GLP) for pivotal nonclinical studies and the documentation necessary for clinical trial applications in the EU. The aim is to provide transparency on the requirements and to clarify the expected level of information on the GLP status to include in the Clinical Trial Application in support of this.

The new recommendation paper is accessible via this link: GLP-recommendation-paper.pdf (hma.eu)

A template matrix recommended to use for clarity and easy overview during assessment is accessible via this link: GLP-recommendation-paper.pdf (hma.eu)