Regulatory Roadmap for the development of human medicinal Products (Europe focus)
Just click on the various stages below to reveal the information.
Research designed to fulfill the requirements of the non-clinical safety section of the common technical document (ICH M4S). Safety evaluation of candidate Investigational Products (New chemical entities and Biologics), known as test articles, governed by Good Laboratory Practice (GLP).
Pre-clinical testing is performed to GLP and covers pivotal toxicology & safety pharmacology studies. This phase continues once clinical trials have commenced to establish the long term safety of new chemical entities.
“Non GxP” Research
Control of Substances Hazardous to Health (COSHH)
ICH Safety Guidelines
|OUTPUTS||Test Article Safety Reports|