Biotech Updates

U.S. Government Updates Federal Regulatory Policy for Biotechnology

September 28, 2016

In September 16, 2016, the United States Federal Government took an important step in ensuring public confidence in their regulatory system for products of biotechnology, and to improve the transparency, predictability, coordination, and efficiency of the system. The U.S. Environmental Protection Agency, U.S. Food and Drug Administration, and U.S. Department of Agriculture released two documents to modernize the Federal regulatory system for biotechnology products.

The first document, a proposed Update to the Coordinated Framework, which was last updated in 1992, is the first time in 30 years that the Federal government has produced a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies with respect to the regulation of biotechnology products. The update also offers to the public a complete picture of the robust and flexible regulatory structure providing appropriate oversight for all products of modern biotechnology.

The second document, the National Strategy for Modernizing the Regulatory System for Biotechnology Products, sets forth a vision to ensure that the Federal regulatory system can assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the Strategy, the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.

To view the documents, visit the White House Blog.