The Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) regulates human cells, tissues, and cellular and tissue-based products (HCT/P) intended for implantation, transplantation, infusion or transfer into a human recipient, including hematopoietic stem cells. The FDA has published comprehensive requirements (current good tissue practice, donor screening and donor testing requirements), to prevent the introduction, transmission and spread of communicable disease. Regulatory requirements for allogeneic products are more extensive than for autologous products. Stem cells come from different sources and are used in a variety of procedures or applications. Stem cells from bone marrow, umbilical cord blood or peripheral blood are routinely used in transplantation procedures to treat patients with cancer and other disorders of the blood and immune system. Stem cells sourced from cord blood for unrelated allogeneic use also are regulated by the FDA, and a license is required for distribution of these products. The FDA requires a review process in which manufacturers must show how products will be manufactured so that the FDA can make certain that appropriate steps are taken to assure purity and potency. Click here for the list of products and how the FDA regulates them.
AABB works with the FDA and other regulatory agencies to assist members with interpretation and compliance with federal regulations.
Every day, stem cell products are transported around the world as part of life saving therapies for patients. As products are collected and transported across international lines additional regulations may apply. These regulations are determined by each individual import and export country. Each country also may have its own local, regional and national regulations on the collection, manufacture and distribution of cellular therapy products. Though the list is not complete, an example of some regulatory requirements may be found here.
The World Health Organization (WHO) serves as the directing and coordinating authority for health within the United Nations system. The World Health Assembly initiated the preparation of the first WHO Guiding Principles on Transplantation, endorsed by the Assembly in 1991. These Guiding Principles have greatly influenced professional codes and practices as well as legislation around the world for almost two decades.
The Federal Food, Drug and Cosmetic Act mandates, as part of the FDA's statutory mission, collaboration with foreign regulatory authorities to reduce regulatory burdens, harmonize regulatory requirements, and establish appropriate reciprocal arrangements. The FDA's international work has grown exponentially over the past decade. Throughout the past few years, the FDA has opened offices in Asia, Europe, India and Latin America.