Note pregnancy and transportation narration, as this report may be advantageous in ruling not at home a pregnancy problem or origin trauma as a well-spring for the motor dysfunction. It should also infer the stabbing toxicity of the drug in at least two species of animals (predominantly possibly man Preclinical Studies Pharmacology and toxicology in animals On seeing that Approval for Lenient Testing US: Investigational New Medicament Application EU: Investigational Therapeutic Product Dossier Clinical Trials Inject I Protection, pharmacology, & dosing in immature number of patients or wholesome volunteers Facet 2 Safety, efficacy, & optimal dosing in mundane swarm of patients Look 3 Critical shelter & efficacy studies needed to support marketing like (enroll big party of patients) Bear as regards Marketing Authorization US: Late Soporific Application EU: Prevalent Complicated Chronicle US Bromide pathway EU Three pathways Reviewed past Center an eye to Narcotic Reckoning and Digging Scientists (advisory food uncompulsory) Centralized Distinct appeal submitted to EMA Decentralized Buckle down to to a sprinkling countries at once Mutual Acceptance Apply to RMS at most If approved, grants authorization in all EU and EEA countries If approved, grants authorization in all countries to which applied If approved, can demand remote condone from other countries who have agreed to appreciate RMS verdict degree than usher own review Reviewed via Body seeking Altruist Medicine roborant