I-Biolex data for Guidance and Organizations

These two datasets were compiled as part of the I-Biolex project. The first dataset presented (guidance) was compiled to understand which regulations, guidelines, and other documents have been effectively produced by the European Commission, the European Medicines Agency (EMA), and other key stakeholders. It constitutes the basic corpus of the research. The second dataset examines the actors participating in consultations on guidelines and regulations, in order to understand the extent to which different organizations have taken part in these consultations, depending on the subject and scope of the documents. These data were collected from open sources, including the EMA website and the European Commission website, among others. Our main contribution was to organize and select the information in order to provide users with a clear and concise picture of European regulation in biotechnology since the 1990s.