IRDiRC Policies & Guidelines

policies and guidelines

IRDiRC Policies and Guidelines refer to the principles that the IRDiRC members agree to follow as well as the recommendations from the Scientific Committees.

The general policies of the IRDiRC emphasize the collaboration in rare diseases research, the involvement of patients and their representatives in all relevant aspects of research, as well as the sharing of data and resources.

Policies and Guidelines are also defined for the following topics: ontologies, diagnostics, biomarkers, patient registries, biobanks, natural history, therapeutics, models, publication and intellectual property, and communication on IRDiRC.

Access the extended version of the Policies and Guidelines


FDA disclaimer: FDA participates as a member of IRDiRC’s committees as a part of the Agency’s efforts to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) including those for the diagnosis and/or treatment of rare diseases or conditions. FDA’s membership in IRDiRC should not be construed as an endorsement of IRDiRC’s specific policies, activities, or products.