This order streamlines the regulation of manufacturing pharmaceutical products and inputs to facilitate the restoration of a robust domestic pharmaceutical manufacturing base.
Within 180 days, the order directs the Secretary of Health and Human Services, through the FDA Commissioner, to review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing.
Within 90 days of the order, the FDA Commissioner is directed to develop and advance improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities involved in the supply of United States medicines, funded by increased fees on foreign manufacturing facilities and the FDA Commissioner must publicly disclose the annual number of inspections that the FDA conducts on such foreign facilities.
Within 180 days, the order instructs the Administrator of the Environmental Protection Agency (EPA) to take action to update regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States to eliminate any duplicative or unnecessary requirements and maximize the timeliness and predictability of agency review.
Within 180 days of the order, the Secretary of the Army, acting through the Assistant Secretary of the Army for Civil Works, shall review the nationwide permits issued under section 404 of the Clean Water Act of 1972 (33 U.S.C. 1344) and section 10 of the Rivers and Harbors Appropriation Act of 1899 (33 U.S.C. 403) to determine whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities.
