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Regulatory Aspects of Personalised Medicines

机译：个性化药物的监管方面

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Abstract: The advent of big data analysis, genetic engineering and epigenetics has transformed the healthcare system by shifting the strategy for diagnosis, prevention and treatment of diseases from "one-size-fits-all" approach to "personalised" approach. Identification of biomarkers from molecular diagnosis has made tailoring of the medical treatment possible. Optimization of treatment decreases the costs related to the ineffective treatments and helps in avoiding possible side effects and adverse drug reactions. The efficient development of personalised medicine is largely dependent on the tools, sequencing techniques used and regulatory policies related to the personalised medicine products, tests and companion diagnostics. The uncertainties in the regulations governing personalised medicine should be eliminated and specific guidelines should be laid down by the respective regulatory authorities to bridge the emerging tools and technologies with the regulatory policies. Also, proper regulatory approval pathways for companion diagnostics will resolve the complications of organized development of therapeutic products and diagnostic tests.
机译：文摘:大数据分析的出现,遗传工程和表观遗传学改变了医疗体系的战略转移诊断、预防和治疗疾病从“一刀切”的方法“个性化”的方法。从分子生物标志物的诊断裁剪的医疗成为可能。优化治疗降低了成本有关无效的治疗和帮助在避免可能的副作用和不良药物反应。个人化药物在很大程度上是依赖于使用工具,测序技术和监管政策与个人化药物有关诊断产品,测试和伴侣。规定的不确定性个人化药物应该取消应该规定具体指导方针各自的监管当局的桥梁新兴的工具和技术监管政策。审批路径同伴诊断解决组织的并发症治疗性产品和发展诊断测试。

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