の 米国食品医薬品局（FDA） has announced a pilot prioritization program のために Abbreviated New Drug Applications (ANDAs) that supports domestic manufacturing and testing. The initiative, launched on October 3, 2025, aims to expedite review timelines for qualifying applications, reduce foreign dependency、 そして boost the resilience of the U.S. pharmaceutical supply chain.
Under the pilot, generic drug manufacturers who conduct bioequivalence testing within the United States, produce finished dosage forms domestically, and source active pharmaceutical ingredients (APIs) exclusively from U.S.-based suppliers are eligible for priority review.
This measure addresses both public health and national security risks by strengthening domestic R&D capabilities and reducing the inspection of costs and delays associated with overseas manufacturing facilities.
Key Provisions and Eligibility
To qualify for priority review, ANDA applicants must fulfill all three of the following criteria:
- Conduct or obtain a waiver for bioequivalence testing in the U.S.
- Manufacture finished dosage forms
- Use API suppliers located in the U.S. [1]
Applicants must reference FDA’s Manual of Policies and Procedures (MAPP) 5240.3 when requesting prioritization under this pilot program. The program is open-ended, with no specified deadline for participation, allowing ongoing submissions under this framework.
なぜそれが重要なのか
The pilot program represents a strategic shift toward onshoring critical pharmaceutical operations。 と over 50% of pharmaceuticals distributed in the U.S. manufactured overseas and only 9% of API manufacturers based domestically, [2] this initiative supports supply chain security, faster market access for generics、 そして enhanced regulatory efficiency.
By incentivizing local production and testing, the FDA aims to bolster public health infrastructure, stimulate domestic R&D、 そして mitigate risks linked to international supply disruptions.
注目すべき人物
このアップデートは特に、 規制関連業務, quality assurance、 そして manufacturing operations teams within generic drug companies. Organizations preparing ANDA submissions should assess their manufacturing geography, testing practices, and supplier base to determine eligibility for the FDA’s expedited review pathway.
次のステップ
利害関係者には次のことが推奨されます。
- Review their manufacturing and testing workflows against the pilot’s eligibility requirements.
- Reference MAPP 5240.3 when submitting ANDAs to request prioritization.
- Maintain supporting documentation to demonstrate compliance with domestic sourcing and testing standards.
For teams navigating regulatory submissions or preparing for shifting U.S. compliance frameworks, leveraging predictive and automated intelligence tools can ensure timely action and submission accuracy.
RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors、 含む life sciences and consumer goods, to proactively navigate complex regulatory landscapes. By leveraging experts in the loop, RegASK delivers predictive actionable insights, end-to-end automation、 そして real-time compliance tracking 横切って 140+ countries streamlining submissions like ANDAs and accelerating market access.
もっと詳しく知る または 今すぐデモを予約してください。
よくある質問
What is the FDA’s new pilot program about?
The program prioritizes review of ANDAs for generic drugs manufactured and tested in the U.S., aiming to strengthen domestic production and reduce reliance on foreign suppliers.
What are the eligibility criteria for priority review?
ANDA applicants must conduct bioequivalence testing in the U.S., manufacture finished dosage forms domestically, and source APIs exclusively from U.S.-based suppliers.
Is there a submission deadline for this pilot program?
No, the FDA has not specified a deadline. Eligible ANDAs can be submitted on an ongoing basis under the pilot framework.
How can RegASK support organizations with this FDA initiative?
RegASK Helps manufacturers and compliance teams monitor evolving FDA policies, automate documentation workflows, and align submission strategies with programs like the FDA’s prioritization pilot to ensure faster, compliant market entry.
