Colombia

In Colombia, multiple authorities are responsible for the oversight and regulation of cellular therapy products. The Ministry of Health and Social Protection is the umbrella authority tasked with the responsibility to formulate, adopt, implement, and evaluate public policy matters pertaining to health of Colombians. The National Institute of Drug and Food Surveillance (INVIMA) is responsible for the regulation and oversight of foods, drugs, medical devices, pharmaceutical, and biological products. Specifically, INVIMA has established decrees, resolutions, and guidelines to assist with tissue and bone marrow banking. These pieces of regulations govern the procurement, donation, preservation, storage, transport, and disposal of human cell and tissue products. They apply to cells and tissues from both living and deceased donors. INVIMA requires that cell and tissue donors be tested for infectious disease and disease agents including syphilis, hepatitis B and C, HTLV I/II, HIV 1/2, Trypanosoma cruzi, cytomegalovirus, and Epstein-Barr virus. Specific details and requirements for cell and tissue banking decrees, regulations, and links to relevant regulatory authorities’ websites are accessible in the Related Information box.