PRECLINICAL RESEARCH IN HUMAN DRUG DEVELOPMENT

The paper presents the preclinical research requirements according to the legislation in force and it’s implementing guidelines in European Union (EU), tracking down it’s origins to ICH when appropriate. The development of any medicinal product requires its research in terms of quality, safety and efficacy. The new codification system for ICH guidelines adopted by ICH Steering Committee is presented in detail. The five categories of CHMP guidelines are explained. The non-clinical research represents a critical stage for the transition to studies in humans. The paper supports the researchers in their efforts to assess the needs and the timelines in the preclinical research fiel