U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) announced that it will apply a review process approximately 10 times faster than before for corporations developing new drugs for U.S. national interests. This announcement came a day after China announced a plan to halve the review period for clinical trials related to new drug development.

On the 17th (local time), the FDA stated in a press release that it will establish the Commissioner’s National Priority Voucher (CNPV) program "to promote the health interests of Americans," noting that the goal is to accelerate the new drug review process for corporations that align with national priorities while maintaining existing strict standards for safety, effectiveness, and quality. Once selected as a priority corporation, the review time after submitting a new drug application (NDA) will be expedited from the previous 10-12 months to 1-2 months.

Previously, the NDA review system involved sending it to multiple FDA offices, but the new CNPV program will handle it through a fast and systematic process by convening various experts within the FDA. Director General Marty Makary said, "The ultimate goal of the CNPV program is to provide more and meaningful treatments to the American public."

Director General Makary also disclosed the eligibility criteria for this program. It includes corporations that can solve the health crisis in the U.S., provide more innovative treatments to American citizens, address public health issues, and expand domestic pharmaceutical manufacturing considering national security issues.

This announcement from the FDA comes in the context of significant organizational restructuring within the agency, which is facing delays in the approval of new drugs from some global pharmaceutical companies. Earlier, on the 2nd, the FDA launched a generative artificial intelligence (AI) tool named Elsa, which can be used in the new drug approval process.

However, some analyze that the recent U.S. FDA action was revealed just a day after China's announcement to shorten the clinical trial review period from 60 days to 30 days, leading to speculation that the FDA may be responding to China.