BIO Comments on Colombia Biologics and Biosimilars Regulations

BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. Many elements of the third draft appear to have addressed BIO’s previous comments with respect to clarity of structure and definitions of terms, as well as expectations for data requirements. We have divided our remaining comments into first tier priorities, and additional concerns.  Please find the links to the full comments below, available in both English and Spanish.