Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacogenomic data disposing 222 biomarkers. Most of them are metabolizing enzymes (46%) and pharmacological targets (41%). The most frequent therapeutic area is oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) (p < 0.00001). Most common biomarkers in Hungarian SmPCs are CYP2D6, CYP2C19, estrogen and progesterone hormone receptor (ESR, PGS). Importantly, US labels present more specific pharmacogenomic subheadings, the level of action has a different prominence, and offer more applicable dose modifications than Hungarians (5% vs 3%). However, Hungarian SmPCs are at 9 oncology drugs stricter than FDA, testing is obligatory before treatment. Out of the biomarkers available in US drug labels, 62 are missing completely from Hungarian SmPCs (p < 0.00001). Most of these belong to oncology (42%) and in case of 11% of missing biomarkers testing is required before treatment. In conclusion, more factual, clear, clinically relevant pharmacogenomic information in Hungarian SmPCs would reinforce implementation of pharmacogenetics. Underpinning future perspective is to support regulatory stakeholders to enhance inclusion of pharmacogenomic biomarkers into Hungarian drug labels and consequently enhance personalized medicine in Hungary.

收集了匈牙利产品特征摘要（SmPC）的药物基因组生物标志物，并将其与美国食品药品监督管理局（FDA）相同活性物质的药物标签中的信息进行了比较（2019年7月）。这些生物标志物的作用水平从药物基因组学知识库中进行了评估。在已识别的264种FDA批准的带有药物基因组生物标记的药物标签中，匈牙利有195种可用。从他们那里，有165种药物包括处理222种生物标记物的药物基因组学数据。它们大多数是代谢酶（46％）和药理学指标（41％）。最常见的治疗领域是肿瘤科（37％），其次是传染病（12％）和精神病学（9％）（p  <0.00001）。匈牙利SmPC中最常见的生物标记是CYP2D6，CYP2C19，雌激素和孕激素受体（ESR，PGS）。重要的是，与匈牙利人相比，美国标签具有更具体的药物基因组学子标题，作用水平有不同的突出程度，并且提供了更多适用的剂量修改方法（5％对3％）。但是，匈牙利的SmPC在9种比FDA更严格的肿瘤药物上，必须在治疗前进行测试。在美国药品标签中可用的生物标志物中，匈牙利SmPC完全缺少62种（p <0.00001）。其中大多数属于肿瘤科（42％），如果缺少11％的生物标志物，则需要在治疗前进行检测。总之，匈牙利SmPC中更真实，明确，临床相关的药物基因组学信息将加强药物遗传学的实施。未来前景的基础是支持监管利益相关者加强将药物基因组生物标记物纳入匈牙利药品标签中，从而增强匈牙利的个性化药品。