FDA 专员国家优先凭证（CNPV）试点项目公开听证会与项目概览
Commissioner's National Priority Voucher (CNPV) Pilot Program
FDA 于6月4日就专员国家优先凭证（CNPV）试点项目举行公开听证会征集意见。该试点2025年6月宣布，采用肿瘤委员会式协作审评，目标审评时限1-2个月，凭证不可转让，覆盖公共卫生危机应对、突破性疗法、重大未满足医疗需求、本土化与供应链韧性、可负担性五类美国国家健康优先事项。入选产品仍须满足相同法定审评要求，审批决定由相关产品中心按常规流程作出。
Accelerated Drug Review for Companies Supporting U.S. National Interests
The Food and Drug Administration is holding a public hearing on June 4 to obtain feedback and perspectives regarding the CNPV Pilot Program.
Program Overview
The FDA Commissioner's National Priority Voucher (CNPV) pilot program is being explored as a pathway to dramatically reduce review times for drug and biological product applications and manufacturing or efficacy supplements.
Announced in June 2025, this innovative program uses a collaborative tumor board-style review process to accelerate review and approval of products that align with one of five critical U.S. national health priorities:
- Public health crisis response - Products addressing urgent/emerging threats or significant population impact.
- Innovative breakthrough therapies - Transformative treatments with novel mechanisms that fundamentally change disease management.
- Large unmet medical needs - Therapies for conditions where existing treatments inadequately address patient outcomes.
- Onshoring and supply chain resilience - Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security.
- Affordability - Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.
Vouchers may be granted by the FDA for review of a company's specific drug/biological product application. Benefits of a voucher include enhanced communications and rolling review to help facilitate a shortened review time.
CNPV Compared To Other FDA Priority Review Programs
- Ultra-fast timeline – 1-2 months target vs. 6+ months
- Nontransferable vouchers
- Enhanced presubmission requests to facilitate expedited rolling review
- Multidisciplinary “tumor board-style” discussion between review team and senior agency leadership
The CNPV pilot is consistent with the FDA’s mission and maintains the FDA’s established safety and effectiveness approval standards, scientific rigor and regulatory compliance requirements. It reflects the FDA's broader commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.
Pre-market applications selected for the Commissioner's National Priority Voucher program will be subject to the same statutory and regulatory requirements for approval as applications that are not included in the program. In addition to receiving the benefits of this program, the agency may also grant an accelerated approval if the product for which the voucher is used meets the applicable legal requirements.
All CNPV applications are reviewed by the appropriate review teams in the relevant FDA center. Review teams will continue to develop independent recommendations based upon their own scientific analysis and share these with a multidisciplinary tumor board-style panel (i.e., CNPV Review Council) for a collaborative discussion. The approval decision remains with the relevant product Center, using the Center’s normal processes.
Additional Information
Voucher Submission
About the Program
- Fact Sheet (.pdf, 229KB)
- FAQs: Commissioner’s National Priority Voucher Pilot Program
- Staff Manual Guide on Commissioner’s National Priority Voucher Review Council (.pdf, 153KB)
- CNPV Town Hall Program Overview (.pdf, 1.45MB)
- Press Announcement - FDA Announces Commissioner's National Priority Voucher (CNPV) Program
Approvals
- October 19, 2026: FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
- August 26, 2026: FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
- July 17, 2026: FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
- July 1, 2026: FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
- May 8, 2026: FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
- April 23, 2026: FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
- April 1, 2026: FDA Approves First New Molecular Entity Under National Priority Voucher Program
- March 19, 2026: FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide
- March 5, 2026: FDA Grants Third Approval Under the National Priority Voucher Program
- February 26, 2026: FDA Grants Second Approval under the National Priority Voucher Pilot Program
- December 9, 2025: First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity | FDA
Voucher Awards
- April 24, 2026: FDA Issues National Priority Vouchers to Three Companies
- December 19, 2025: FDA Grants Two National Priority Vouchers | FDA
- December 15, 2025: FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results | FDA
- November 6, 2025: FDA Awards Second Batch of National Priority Vouchers
- October 16, 2025: FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
Public Hearings
- June 4, 2026: CNPV Pilot Program Public Hearing
来源：FDA 官方药品与生物制品信息 · fda.gov