Abstract：
UNASSIGNED: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA.
UNASSIGNED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan.
UNASSIGNED: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.
UNASSIGNED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan.
UNASSIGNED: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.
摘要：
■重组基于病毒的基因治疗产品，例如掺入腺相关病毒（AAV）的那些，属于转基因生物（GMOs）类别。在开始任何临床试验之前，欧盟（EU）国家和日本必须获得环境风险评估（ERA）批准才能使用转基因生物。据报道，由于ERA的监管程序和文件准备时间较长，这两个地区含GMO产品的开发遇到了一些监管障碍。
■在本文中，我们比较分析了欧盟和日本对基于AAV的重组医药产品的ERA文件要求,以突出未来可能尝试融合的背景下的差异.此外,我们分析了非临床和临床数据需求，这是欧盟和日本ERA审查的关键组成部分。最后,我们比较了遏制措施，以最大程度地减少转基因生物在欧盟和日本的环境中的传播。
■根据我们的比较分析，我们提出了规范和简化欧盟和日本转基因生物ERA法规申请材料和程序的若干政策建议，以及实现全球监管趋同的长期时间表。
■在本文中，我们比较分析了欧盟和日本对基于AAV的重组医药产品的ERA文件要求,以突出未来可能尝试融合的背景下的差异.此外,我们分析了非临床和临床数据需求，这是欧盟和日本ERA审查的关键组成部分。最后,我们比较了遏制措施，以最大程度地减少转基因生物在欧盟和日本的环境中的传播。
■根据我们的比较分析，我们提出了规范和简化欧盟和日本转基因生物ERA法规申请材料和程序的若干政策建议，以及实现全球监管趋同的长期时间表。
