Guidelines on management of blood and blood components as essential medicines, Annex 3, TRS No 1004

Overview

Essential medicines (EMs) are defined by WHO as those medicinal products that satisfy the health-care needs of the majority of the population. They should therefore be available at all times, in adequate amounts and in appropriate
dosage forms, with assured quality and affordability. The WHO Model List of Essential Medicines1 was first generated in 1977 and has been updated every 2 years since then. In accordance with resolution WHA63.12, and in recognition of the fact that achieving self-sufficiency in the supply of safe blood is an important national goal in preventing blood shortages and meeting the transfusion needs of the patient population, blood and blood components (whole blood, red blood cells (RBCs), platelets and fresh frozen plasma) were added to the 18th edition of the core list of the WHO Model List of Essential Medicines in 2013. 

These WHO Guidelines are intended to provide a framework for establishing regulatory oversight of blood and blood components for use in transfusion as EMs. The underlying concept is that blood and blood components are biological
therapeutic products of human origin whose preparation should be subject to regulatory standardization and oversight to assure their quality, safety and efficacy. The framework provided in these Guidelines is similar to that which is widely applied to the regulation of drugs produced under current GMP (cGMP) but is adapted to address the specific attributes of blood and blood components for transfusion that distinguish them from PDMPs and from pharmaceutical medicines (drugs) in general. In jurisdictions where the legal frameworks in place for medicines manufactured under cGMP for pharmaceuticals would not apply to blood and blood components, parallel regulation based on the model provided in these Guidelines would involve application of the analogous “GPP” for such products.