USFDA's: FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program to Accelerate Life-Changing Medicines

The U.S. Food and Drug Administration (FDA) has launched the "Commissioner’s National Priority Voucher (CNPV) Pilot Program" a transformative regulatory pathway designed to fast-track the development and review of drugs and biologics that target critical U.S. national health priorities.

Background and Why This Matters

The U.S. pharmaceutical supply chain relies heavily on active pharmaceutical ingredients (APIs) and components from China, raising clear national security risks. These examples reflect why FDA and industry must act urgently: to develop transformative products that both advance public health and secure America’s critical medical supply chains.

The CNPV pilot focuses on advancing drugs and biologics that align with one or more national priorities:

• Addressing a U.S. public health crisisFor instance, a universal flu vaccine protecting against seasonal and pandemic influenza strains.

• Delivering more innovative curesSuch as novel immunotherapies reprogramming the immune system to fight multiple diseases, or transformative mental health treatments like a new therapy for PTSD.

• Addressing large unmet medical needsIncluding new drugs to treat or prevent rare diseases, or addressing chronic diseases that current therapies don’t adequately manage.

• Onshoring drug development and manufacturingFor example, moving production of essential medicines (like sterile injectables) to new U.S. facilities, or designing clinical trials that keep substantial U.S. patient enrollment to ensure data generalizability.

• Increasing affordabilityExamples could include drugs priced using Most Favored Nation benchmarking or those that lower downstream healthcare costs by reducing hospital admissions.

• Uniquely, the program prioritizes broad public health impact, unlike some existing FDA programs that target only small patient groups.
  

Benefits:

Companies selected for the pilot benefit from:

• Ultra-accelerated review timelines — reducing FDA review from around 10–12 months to about 1–2 months

• Enhanced, ongoing communication with FDA experts

• Multidisciplinary, senior-level team review, led by FDA’s Office of the Chief Medical and Scientific Officer

• Potential for accelerated approval, if legal criteria are met

• Continued rigorous FDA safety and efficacy standards

To support the faster timeline, participants must submit the CMC (chemistry, manufacturing & controls) section and proposed labeling at least 60 days before submitting the full pre-market application.

Eligibility Criteria

To apply, a company must demonstrate its product aligns with at least one program priority.Key points:

• Each company can submit only one application.

• FDA may grant:

  • A voucher linked to a specific product

  • Or an undesignated voucher that can later be used for another product, if it aligns with program objectives

All pre-market applications still must meet existing FDA approval requirements.

FDA’s senior multidisciplinary committee will:

• Select up to five participants in the first year

• Prioritize applications closest to marketing readiness and those addressing national health priorities

• Contact promising companies for informational meetings if needed

For more details, including eligibility, application process, and FAQs, visit: FDA: Commissioner's National Priority Voucher (CNPV) Pilot Program