ANSM Creates New Unit to Handle Early Stage Clinical Trials
France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials.
Starting next week, the unit will begin managing all clinical trials classified as first-in-human and early clinical trials, including “those which generate initial knowledge in humans on tolerability, safety, pharmacokinetics and pharmacodynamics for medicines.”
The unit will not be involved with clinical trials that involve cell and gene therapy products, medical devices, vaccines, cells, tissue or organs.
ANSM’s plans come in response to a fatally flawed Phase 1 French trial that left one patient dead and five injured in 2016 and triggered an in-depth investigation set up by the agency.