I- BioLex dataset on organisations

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 (organisations) was compiled to identify the organisations participating in consultations on guidelines and regulations in the field of biological medicinal products since the 1990s. It is partly based on the I-BioLex dataset on guidance (available here: https://doi.org/10.5281/zenodo.17591115). But it has been extended with the integration of selected European Union legislations. Our main research objective was to identify organisations involved in the field, and to understand the extent to which different organizations have taken part in these consultations, depending on the subject and scope of the documents. Our main contribution has been to provide a clear and concise picture of the organisations involved in the field of biological medicinal products through answers to public consultations in the European Union. 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.