The Imperfect Intellectual Bridge Between a Master Medicinal Product and Its Associated Custom-Made Medicinal Products

Abstract

To obtain a license to be placed on the marketplace, a medicinal product must be accompanied by data on quality and data from preclinical studies and studies of clinical safety and efficacy. At the time of first production, a custom-made medicinal product will have data on quality but will not be accompanied by data from preclinical studies or from studies of clinical safety and efficacy. To span the gap in data, an “imperfect intellectual bridge” between data for a custom-made medicinal product and data for its master medicinal product is described. The imperfect intellectual bridge will allow the custom-made medicinal product to draw on data associated with its master medicinal product. In time, it may be possible for a custom-made medicinal product to transfer to an independent license after collection of data on clinical safety and efficacy by means of a pharmacovigilance exercise.