US agencies present plan to modernize biotechnology regulations

The U.S. FDA, Environmental Protection Agency and Department of Agriculture responded to President Biden’s call with a comprehensive plan to change biotechnology regulations. The plan, under Executive Order 14081 issued in September 2022, aims to modernize regulations governing the development and manufacturing of biotechnology products, from industrial goods to CRISPR technologies. Feedback from stakeholders, including input from industry groups and public comment, shaped the plan, highlighting the need for transparency, synchronization and updating of existing regulations.

Future policy initiatives outlined in the plan include proposed changes to the Chemistry, Manufacturing and Controls (CMC) changes once approved, as well as the establishment of a Platform Technology Designation Program to accelerate the development of gene editing products. Additionally, efforts are underway to streamline regulatory processes for gene editing therapies, focusing on reducing burdensome requirements while ensuring standards of safety and effectiveness. The plan signals a concerted effort by U.S. agencies to adapt the regulatory framework to advances in biotechnology, support innovation and address emerging challenges in the field.

read more