The National Strategy for Modernizing the Regulatory System for Biotechnology Products

The National Strategy for Modernizing the Regulatory System for Biotechnology Products (Strategy), was published in September of 2016 along with the 2017 Update to the Coordinated Framework (see our previous post).  While the 2017 Update to the Coordinated Framework clarifies the current roles and responsibilities of each agency (EPA, FDA, USDA) in regulating biotechnology products, the goal of the Strategy is: 

 “[…] to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, […] and reducing unnecessary costs and burdens”. 

 The Strategy includes a summary of current and future activities by EPA, FDA and USDA that work to fulfil the goals of this strategy to:  

(1) increase transparency: including public meetings and workshops; public outreach through agency websites, guidance, and newsletters; and future review and development of communication tools. 

(2) increase predictability and efficiency: including horizon scanning to detect new development in biotechnology; encouraging discussions with product developers early in the R&D phase, regulatory guidance documents; and efforts to enhance inter-agency collaboration and communication.  

(3) support the science that underpins the regulatory system: including collaborations with Federal research agencies as well as in-house and external research to address scientific gaps and develop models, methods and approaches to inform regulatory policy and decision making.