I- BioLex dataset on guidance

This dataset was compiled as part of the I-Biolex research project funded by the French National Agency for research (ANR-20-CE26-0007-01 ; PI: A. Mahalatchimy). More information on the project can be found at: https://elsibi.hypotheses.org/i-biolex The dataset presented (guidance) was compiled to identify which regulations, guidelines, and other documents have been effectively produced by the European Commission, the European Medicines Agency (EMA), and the ICH mainly, in the field of biological medicinal products since the 1990s. It constitutes the basic corpus of an essential part of the research conducted in I-BioLex. These data were collected from open public sources, including the EMA website and the European Commission website, among others. These data were organised and classified in order to permit analysis of the existing overlapping over time between legal subcategories of biological medicinal products. Our main contribution has been to provide the first clear and concise picture of the European guidance in the field of biological medicinal products. Several open access papers have or will be published on the basis of this initial dataset in the context of I-BioLex. This dataset can be used for research purposes beyond I-BioLex, upon request and clear reference to the source, as provided here.