Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.

基因驱动改良蚊子 (GDMM) 正在开发中，作为预防疟疾和其他蚊媒疾病传播的可能的新工具。迄今为止，还没有 GDMM 接受过现场测试。这个早期阶段是开发人员、支持者和可能的用户开始考虑在国家或地区公共卫生计划中最终实施这些技术的潜在监管要求的好时机，特别是因为这些要求的一些实际影响可能需要相当大的时间计划、时间和协调来解决。与 GDMMs 的实施相关的几个目前未解决的监管问题被审查，包括：如何定义产品；将新的 GDMM 产品投放市场的注册/批准程序是什么；如何解决 GDMM 越境转移的可能性；现有多国机构和协议在授权决定中可以发挥什么作用。评估适用于注册其他转基因生物或其他活蚊子产品的法规和政策与 GDMM 在非洲预防疟疾的用例的相关性。根据每个国家针对某些产品类别的现行法律，多个国家当局可能会参与决策。《卡塔赫纳生物多样性议定书》的要求将被认为与大多数国家相关，现有的常规农药、医疗和生物防治产品监管框架也是如此。经验表明，标准监管流程、证据要求、和责任法因国家/地区而异。区域机制将有助于应对一些重要挑战。