Are you working with the non-clinical package for clinical trial applications? See Q&A-update!
Improved overview of GLP status for pivotal animal studies across all stages of drug development
The Q&A for the Clinical Trials Regulation (CTR) (Section 1.19, Question 62) has been updated, and the CTCG Cover Letter template has been revised to include checkboxes. This allows sponsors to indicate the GLP status to provide a clearer overview.
It is the sponsor’s responsibility to assess the implications of any change in a test facility’s GLP status and to notify the relevant authorities through CTIS for all affected clinical trials. This is intended to ensure that information on medicinal products under development remains up to date, thereby maintaining the highest possible level of safety for patients participating in clinical trials. It also helps ensure confidence in the quality of the animal studies that may form part of the basis for a future marketing authorisation application.
A direct link to the updated Q&A can be found here (see page 16, Section 1.19, Question 62 for the relevant information).
Link to the Q&A webpage.
Link to the CTCG Cover Letter template.
Read more here: Non-clinical regulatory advice - including GLP