On April 29, 2026, The United States House Committee on Appropriations added a provision to the FDA-related federal spending bill report, prohibiting the FDA from "accepting, reviewing, or considering" clinical data generated at sites in China, Russia, Iran or North Korea in support of IND applications.

The report shows multiple so-called concerns from the committee, including risks of intellectual property theft, the possibility that clinical trial ethical standards may be lower than those in the U.S., and human rights issues.

Although the Committee report lacks legal force, it has significant practical influence. However, for the provision to become law, it must still go through multiple stages of the legislative process. Furthermore, according to the current text, even if the legislation, the ban would apply to IND applications submitted one year after the date of enactment, enabling the FDA has sufficient time to develop implementation guidance.

It should be also noticed that the core data at the IND stage is not clinical data, and the report does not mention banning Chinese data for New Drug Applications (NDAs) or Biologics License Applications (BLAs), which may be a strategic choice by lawmakers: the IND stage is the first gateway for data to enter the FDA examination process. By imposing restrictions at this stage, the inflow of Chinese data (and thus Chinese investigational drugs) can be blocked at the source, while avoiding a direct impact on mature pipelines that have already advanced to the NDA stage.

The industry is now trying to strike a balance on two aspects: pushing for FDA reforms to accelerate the entry of U.S. drugs into clinical trials, while simultaneously preserving high-quality Chinese drug assets and necessary data from China.

From Sino finance

May 6th, 2026