The BIOSECURE Act is now law in the United States as of December 2025.
Even so, it introduces new compliance considerations for U.S. biotech and pharmaceutical companies who deal with Chinese vendors—and creates meaningful opportunities for global vendors located outside China.
The Act restricts U.S. executive branch agencies from contracting with, or providing grants or loans to, companies that rely on biotechnology equipment or services supplied by designated “biotechnology companies of concern.” The definition of biotechnology services covers research tools, software, manufacturing support, data-related services, and R&D activities
Unlike early drafts, the Act relies on two mechanisms to identify companies of concern.
- The first is the Department of War’s existing “Section 1260H” list, which focuses on entities linked to China’s military-industrial ecosystem.
- The second is a new list to be developed by the Office of Management and Budget (OMB) using national security criteria, including government control, military or intelligence ties, and improper handling of sensitive human biological data. Subsidiaries and successor entities may also be captured under this framework.
implementation will occur gradually, with restrictions unlikely to take effect until 2028, and with grandfathering provisions that delay compliance obligations for certain existing contracts until the early 2030s
The most affected organizations are likely to be those that depend heavily on federal grants, defense-related research contracts, or Veterans Administration procurement and that use China-linked CROs, CDMOs, or data platforms. While the Act is law uncertainty remains until OMB guidance and revised federal acquisition rules clarify how broadly the restrictions will be applied and this may take several months.
. From a global perspective, the BIOSECURE Act may significantly benefit biotechnology suppliers based outside China.
As companies reassess supply chains and research partnerships to minimize future regulatory risk, demand is likely to increase for CROs, CDMOs, and technology providers located in countries viewed as geopolitically aligned and operationally transparent. Providers in India, Europe, Japan, South Korea, and Israel are particularly well positioned if they can demonstrate strong compliance, data governance, and independence from foreign government influence.
The BIOSECURE Act is a signal of a growing American preference for trusted, diversified global biotechnology ecosystems—one that constrains certain China-linked relationships while opening the door for alternative partners worldwide
