Somatic gene therapies may be authorised for marketing in the EU under the advanced therapy medicinal product regulation. These therapeutic compounds are sufficiently novel and complex in their potential effects to require specialist evaluation. However, the current definition of gene therapy medicinal products (‘GTMP’) risks excluding molecules which are not manufactured through techniques involving recombination. We consider the way, in which the ‘recombinant nucleic acid’ aspect of the GTMP definition is challenged by developments in gene-editing technology, and why a broader scope of GTMP regulation may be desirable.

中文翻译：

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基因疗法的法规：体内编辑是否可以通过网络进行？

根据先进疗法药物产品法规，可以授权在欧盟销售体细胞基因疗法。这些治疗性化合物具有足够新颖和复杂的潜在作用，需要专家评估。但是，目前基因治疗药物（'GTMP'）的定义可能会排除不通过涉及重组技术制造的分子的风险。我们考虑了基因编辑技术的发展挑战GTMP定义的“重组核酸”方面的方式，以及为什么可能需要更广泛的GTMP调节范围。