Pharmacogenetic Information on Drug Labels of the Italian Agency of Medicines (AIFA): Actionability and Comparison Across Other Regulatory Agencies.

ABSTRACT: To plan future steps for the implementation and regulation of pharmacogenetic testing, any issue in the management of pharmacogenetic information by regulatory bodies must be identified. In this paper, an analysis of pharmacogenetic information in the summary of product characteristics (SmCPs) of drugs approved by Italian Drug Agency (AIFA) was conducted. Among 4214 SmCPs of 1063 active ingredients, 53.2% (n = 2240) included pharmacogenetic information in at least one section, most frequently for drugs in the Anatomical Therapeutic Chemical category "Antineoplastic and immunomodulatory agents". To contextualize these data in the international scenario, a pharmacogenetic level of actionability, based on AIFA SmCPs, was assigned to 608 drug/gene pairs included in FDA's "Table of Pharmacogeno

SUBMITTER: Moschella A 

PROVIDER: S-EPMC11799589 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature