The specific case of radiopharmaceuticals and GMP—activities of the Radiopharmacy Committee
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We have read with great interest the Editorial by Långström and Hartvig  discussing the increasing demands from current Good Manufacturing Practice (cGMP) regulations for radiopharmaceutical preparations. We agree with the authors that regulatory issues have had a dramatic impact on the development of radiopharmaceutical preparation and also on the Nuclear Medicine Community in general over the last years. Notwithstanding the importance of GMP regulations to ensure adequate safety, quality and potency of medicinal products, it also has to be considered that the application of current GMP regulations to the non-commercial production of radiopharmaceuticals, mainly for in-house use, is imposing excessive hurdles on the everyday work of thousands of nuclear medicine practitioners across Europe. Furthermore, the application of a legislation framework designed for the industrial production and marketing of non-radioactive medicinal products to the whole radiopharmaceutical...