Quality in Non-Licensed Radiopharmaceutical Products: Are We Achieving the Goal?

Abstract

Radiopharmaceutical compounds, considered a special group of medicines, can be prepared outside the marketing authorisation track. Small-scale preparations at non-commercial sites thereby represent an important segment, however a lack of harmonisation in the regulation leads to extreme differences in the application and availability of radiopharmaceuticals across Europe. A number of guidelines and guidance documents have been issued by European Association of Nuclear Medicine (EAMN), Pharmaceutical inspection convention (PICs), European Directorate for the Quality of Medicines & HealthCare (EDQM) to achieve a good radiopharmacy practice for small-scale preparation. Nevertheless, in the case of non-licensed radiopharmaceuticals their consideration as magistral formulas, in some countries, makes it possible to waive regulatory inspections aimed to ensure those good practices enforcement. Moreover, special attention should be put on the quality assurance process for non-licensed starting materials, given that the final radiopharmaceuticals quality chiefly depends on it. This paper (chapter) will provide an insight into the quality standards applicable to starting materials, such as supplier qualification control, starting material re-test period, etc. in order to raise for discussion about how best to achieve a proven quality, efficacy, and safety for our radiopharmaceuticals (licensed or non-licensed).