The purpose of this study was to summarize the historical changes in the list of plasma fractionation products (PFP) placed on the Model List of Essential Medicines (EML) issued by the World Health Organization (WHO). PFP such as albumin, blood coagulation factors, and immunoglobulins are derived from blood collected from thousands of people. PFP have been listed since the first edition of the EML (1977). However, the PFP listed on the EML have changed dramatically because EML's selection process has changed from experience-based to evidence-based. For example, albumin, which had been listed since the 2nd edition (1979), was deleted in the 11th edition (2000) because of the uncertainty of its efficacy. Human immunoglobulin normal, which had been deleted from the 13th edition (2003), was relisted in the 15th edition (2007). Moreover, the WHO has issued several resolutions and guidelines regarding PFP production, quality, and safety in order to promote the establishment of blood programmes in every nation. The focus of WHO's EML selection process has changed over 30 years. In the 20th century, WHO mainly focused on PFP efficacy, quality, and safety problems. However, currently the focus is on the problem of PFP accessibility, especially in developing countries. Therefore, it would be important to know how to capitalize on established knowledge and production technology to increase the accessibility of PFP worldwide.
2014 by the PHARMACEUTICAL SOCIETY OF JAPAN