Executive Order
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Regulatory Relief To Promote Domestic Production of Critical Medicines
AI Summary:
This regulation is an executive order aimed at streamlining and expediting domestic pharmaceutical manufacturing in the United States. The order directs several federal agencies, including the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Army Corps of Engineers, to review and update their regulations and guidance to reduce barriers to establishing and expanding pharmaceutical production facilities. Key actions include the FDA reviewing its inspection and approval processes to make them more efficient and predictable, improving oversight of foreign manufacturing facilities, and establishing the EPA as the lead agency for environmental permitting of pharmaceutical manufacturing facilities. The order seeks to reduce the time and complexity of building new pharmaceutical manufacturing capacity, which currently can take 5 to 10 years, by eliminating duplicative requirements, providing clearer guidance, and coordinating permit reviews. The goal is to enhance the United States' domestic pharmaceutical manufacturing capabilities and improve national security by reducing reliance on international supply chains.