This work aimed to analyse the pharmacogenetic information in the Spanish Drug Regulatory Agency (AEMPS) Summary of Products Characteristics (SmPC), evaluating the presence of pharmacogenetic biomarkers, as well as the associated recommendations. A total of 55.4% of the 1891 drug labels reviewed included information on pharmacogenetic biomarker(s). Pharmacogenomic information appears most frequently in the “antineoplastic and immunomodulating agents”, “nervous system”, and “cardiovascular system” Anatomical Therapeutic Chemical groups. A total of 509 different pharmacogenetic biomarkers were found, of which CYP450 enzymes accounted for almost 34% of the total drug-biomarker associations evaluated. A total of 3679 drug–biomarker pairs were identified, 102 of which were at the 1A level (PharmGKB^® classification system), and 33.33% of these drug-pharmacogenetic biomarker pairs were assigned to “actionable PGx”, 12.75% to “informative PGx”, 4.9% to “testing recommended”, and 4.9% to “testing required”. The rate of coincidence in the assigned PGx level of recommendation between the AEMPS and regulatory agencies included in the PharmGKB® Drug Label Annotations database (i.e., the FDA, EMA, SWISS Medic, PMDA, and HCSC) ranged from 45% to 65%, being ‘actionable level’ the most frequent. On the other hand, discrepancies between agencies did not exceed 35%. This study highlights the presence of relevant pharmacogenetic information on Spanish drug labels, which would help avoid interactions, toxicity, or lack of treatment efficacy.

这项工作旨在分析西班牙药品监管局 (AEMPS) 产品特性摘要 (SmPC) 中的药物遗传学信息，评估药物遗传学生物标志物的存在以及相关建议。在审查的 1891 个药物标签中，总共 55.4% 包含药物遗传学生物标志物信息。药物基因组信息最常出现在“抗肿瘤和免疫调节剂”、“神经系统”和“心血管系统”解剖治疗化学组中。总共发现了 509 种不同的药物遗传学生物标志物，其中 CYP450 酶几乎占评估的药物生物标志物关联总数的 34%。总共鉴定了 3679 个药物-生物标志物对，其中 102 个处于 1A 级别（PharmGKB®^分类系统），这些药物-药理学生物标志物对中的 33.33% 被分配给“可操作的 PGx”，12.75% 被分配给“信息性 PGx” ”，4.9% 表示“建议进行测试”，4.9% 表示“需要进行测试”。AEMPS 与 PharmGKB® 药物标签注释数据库中包含的监管机构（即 FDA、EMA、SWISS Medic、PMDA 和 HCSC）之间指定的 PGx 推荐水平的一致率为 45% 至 65%，最常见的是“可操作级别”。另一方面，各机构之间的差异不超过35%。这项研究强调了西班牙药物标签上存在相关药物遗传学信息，这将有助于避免相互作用、毒性或缺乏治疗功效。