John Innes Centre, Norwich Research Park, Norwich, NR4 7UH, UK.
Curr Pharm Des. 2013;19(31):5513-30. doi: 10.2174/1381612811319310007.
In this article, the general principles of genetically modified (GM) plant risk assessment and the regulatory framework for contained use and open field production of plant-made pharmaceuticals/plant-made industrials (PMP/PMI) are described. While significant progress has been made for the containment grown (plant cell culture) production of PMPs, with the first regulatory approval made by the FDA in 2012, the commercialization of medicinal or industrial products produced in the field has yet to emerge in either Europe or the US. In the current paper, we discribe the regulatory environment in Europe and the US surrounding GM crops, and provide case studies for experimental field releases of PMP and PMI producing plants in both regions. Suggestions for reducing the regulatory burden for GM plants will be discussed, also in light of the emerging new technologies to modify the genetics of plants. Since regulations surrounding the commercialization of GM crops are very costly and not appropriate for most of the PMP/PMI applications in Europe, we propose that amendments to the EU Directive 2001/18/EC are necessary to allow for the commercialization of products from GM plants without the need of an 'authorization'. To fully acknowledge the overall outcome of adopting plants to produce PMP/PMI, the conclusion is that broader and more balanced legislative oversight is needed in Europe; while specific legislation is not needed in the US.
本文描述了基因修饰（GM）植物风险评估的一般原则，以及用于限制使用和开放田间生产植物药物/植物工业制品（PMP/PMI）的监管框架。虽然在 containment grown（植物细胞培养）生产 PMP 方面已经取得了重大进展，美国 FDA 于 2012 年首次批准，但在欧洲或美国，尚未出现田间生产的药用或工业产品的商业化。在本文中，我们描述了围绕 GM 作物的欧洲和美国的监管环境，并提供了这两个地区 PMP 和 PMI 生产植物的实验性田间释放的案例研究。我们将讨论降低 GM 植物监管负担的建议，同时也考虑到新兴的植物遗传修饰新技术。由于围绕 GM 作物商业化的监管非常昂贵，并且不适合欧洲大多数 PMP/PMI 应用，因此我们建议对欧盟指令 2001/18/EC 进行修订，以允许在无需“授权”的情况下商业化来自 GM 植物的产品。为了充分承认采用植物生产 PMP/PMI 的总体结果，我们得出的结论是，欧洲需要更广泛和更平衡的立法监督；而美国则不需要具体的立法。
