September 19, 2016

White House Announces Updates to Modernize Biotech Regulations

White House
The White House in Washington, D.C. Source: WIkipedia https://commons.wikimedia.org/wiki/File:White_House_DC.JPG

The White House just announced its updates to the coordinated framework for the regulation of biotechnology products. Its ongoing process to modernize the regulatory process has been going on for the last year and has been receiving input from the industry, academia, NGO groups and members of the public.

EPA, FDA, and USDA have released two documents – a proposed Update to the Coordinated Framework for the Regulation of Biotechnology and a National Strategy for Modernizing the Regulatory System for Biotechnology Products. These documents present a comprehensive summary of the current roles and responsibilities of the three primary regulatory agencies with respect to the regulation of biotechnology products and a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.

The new process announced articulates what regulatory parts should be taken for which product and which agencies regulate them as well as the update to the coordinated framework.

The White House also published a strategic plan outlining the various steps that will be taken in the future to ensure that the regulatory process remains updated as new biotech tools, technologies and products come online.

We’ll be discussing this important update at SynBioBeta SF 2016 on Wednesday, the 5th of October, during our regulatory panel.