Estrella Moya SánchezSpanish Agency of Medicines and Medical Devices, Spain
Title: Quality in non-licensed radiopharmaceutical products. Are we achieving the goal?
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 harmonization 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 EAMN, PICs, 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 will provide an insight in 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).
Estrella Moya Sánchez, Radiopharmacist specialist and graduated in Pharmacy has a decade experience as Quality Assessor in the Spanish Agency of Medicines and Medical Devices (AEMPS) and Assessor Expert in the European Medicines Agency (EMA). Previously, she had been working as a Hospital Radiopharmacist and as a Product and Quality Manager in a Laboratory PET. Estrella specialized in the assessment of the quality in the radiopharmaceuticals clinical trial authorisation applications, is also member of several expert groups involved on the Radiopharmaceuticals regulation. Estrella regularly collaborates as educational staff in several master’s degrees where she takes great pride in teaching on radiopharmacy