Abstract
Abstract
European Union Legislation in the sector of biological medicines is complemented by a substantial volume of guidance documents which are essential for strategic choices regarding biologicals development from lab to patients, especially authorisation processes as regards to quality, safety, and efficacy aspects. This corpus of guidance documents has historically been underutilised for research. Hence, the I-BioLex project has focused on both documents and actors, in a genealogical perspective. The two datasets presented in this paper gather all guidance documents relevant to this field, with comprehensive metadata, as well as a list of all contributors to public consultations conducted during the process of adoption or revision of these guidance documents in the field of biologicals at the EU level from 1990 to 2026. It constitutes an original foray into interdisciplinary research at the crossroads of social sciences (law, sociology,…) and biomedical sciences (medicine, pharmacy,…) in order to better understand how guidance documents are shaped and who is influencing them, in the field of biologicals.