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The use of advanced therapy medicinal products (ATMPs) to treat disease and injury is growing. The European Commission (EC) noted this in its Pharmaceutical Strategy for Europe which also touches on ATMPs in the section covering enabling innovation and digital transformation.1 The European Medicines Agency (EMA) plays a central role in the authorisation of new therapies and included supporting the translation of ATMPs into patient treatments as one of the strategic goals and a core recommendation for human medicines in its Regulatory Science to 2025 Strategy.2

Within the European Union (EU), ATMPs are centrally regulated3 and cover biological medicinal products that can be classified as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered medicinal products (TEPs) or any combination of the three.4 They are often injectable and all healthcare professionals, including hospital pharmacists, need to understand how to handle ATMPs safely. Indeed, hospital pharmacists not only encounter ATMPs during clinical trials but also during regular clinical practice and may be called on to reconstitute them.

This position paper of the European Association of Hospital Pharmacists (EAHP) outlines the roles and responsibilities of hospital pharmacists in the handling of ATMPs, addresses their education and training in relation to these products and provides insights on the assessment of ATMPs and pharmacoeconomics.