Plasma-derived medicinal products (PDMPs) are prepared industrially from human plasma by pharmaceutical companies and include products such as albumin, coagulation factors and immunoglobulins, which are life-saving therapeutics for several chronic and acute life-threatening diseases. The relevance of some of these products is confirmed by their inclusion in the World Health Organisation Essential Medicines Lists. Plasma collected by Italian Blood Establishments derives from voluntary non-remunerated blood donations. The Italian Regions and Autonomous Provinces (RAPs), individually or in association, send plasma produced according to regional and national plans to Kedrion Biopharma (Kedrion SpA, Castelvecchio Pascoli, Lucca, Italy), which is currently the only manufacturer authorised to fractionate national plasma upon toll fractionation agreements. Importantly, RAPs remain the owners of plasma sent for fractionation, as well as of manufactured PDMPs and of the residual raw material, including discards. According to current contracts, Kedrion Biopharma provides for the manufacturing of the following PDMPs: human albumin solution (albumin), polyvalent immunoglobulin for intravenous administration (IVIG), factor VIII concentrates (FVIII), factor IX concentrates (FIX), prothrombin complex concentrates (PCCs) and antithrombin (AT). For the purpose of a systematic analysis of the Italian demand for PDMPs, the National Blood Centre (NBC) developed a collaboration with the Information Systems Office of the Ministry of Health (MoH) resulting in the production of a full report on the "Demand for the main plasma derived medicinal products in Italy, Years 2007-2011". The NBC -designated as the Italian blood and blood product competent authority operating on behalf of the MoHcoordinates and supervises the 21 Regional Blood Centres, with the goal of guaranteeing blood and blood component self-sufficiency and a homogeneous and standardised application of national and European blood regulations throughout the blood supply and transfusion chain, particularly as concerns quality and safety. The achievement of self-sufficiency is recognised as "a national, supra-regional, supra-local indivisible interest of the National Health Service" to be pursued with the contribution of the regional health authorities. Every year, the NBC must provide technical indications to the MoH for the definition of an Annual National Programme for Self-sufficiency. Moreover, it must provide technical indications for a programme on the development of plasma collection and the promotion of an appropriate and rational use of PDMPs. To facilitate the latter objective, a complete assessment of population needs and an in-depth analysis of PDMP utilisation at regional and national level are required as preliminary steps. The above mentioned report, the first document ever produced in Italy utilising institutional data, analyses the regional and national demand for the main PDMPs from 2007 to 2011, including those obtained from the toll fractionation contracts currently in place. Hence, the report provides the information required to support planning and adoption of national PDMP self-sufficiency policies, also considering that it will be systematically updated. The eighteen articles published in this Special Issue of Blood Transfusion represent a commendable initiative so far lacking in the transfusion medicine scenario. In fact, this Issue deals not only with the demand, the challenges and perspectives of PDMP clinical use but also focuses on the evolution of the Italian regulatory framework for PDMPs as well as the hot topics in the drive for blood product self-sufficiency. In addition, an estimate of public expenditure for PDMPs and inherent recombinant medicinal products is thoroughly addressed, and an article showing that a national programme for PDMP self-sufficiency developed and governed by the public blood system can be economically sustainable (provided standard costs of blood component production are appropriately pursued and maintained) concludes the series of contributions. In Italy, the demand for PDMPs is significantly, though partially, met by the products supplied by toll fractionation contracts. National self-sufficiency in PDMPs depends heavily both on the appropriate clinical use of plasma, which allows an adequate supply of raw material for industrial fractionation,