BIOSECURE Act was officially signed into law as part of the FY 2026 National Defense Authorization Act (NDAA) on December 18, 2025. This landmark legislation restricts U.S. federal agencies and their contractors from utilizing “biotechnology companies of concern,” forcing a massive shift in the pharmaceutical supply chain away from dominant Chinese CDMOs.
Compliance with the BIOSECURE Act
According to legal experts at Morrison Foerster (Dec 2025), the BIOSECURE Act includes a five-year grandfathering period for existing contracts, but the “de-risking” process has already begun. Companies are rapidly diversifying their CRO and CDMO footprints into Southeast Asia, India, and the U.S.
- Designated Entities: While early versions named specific firms, the final law grants the OMB until December 2026 to publish the full list of Biotechnology Companies of Concern.
- Onshoring Momentum: 10-K filings from 2026, such as those from Baker McKenzie, show a 40% increase in U.S.-based clinical manufacturing investment.
- Data Sovereignty: China’s stringent HGR laws continue to restrict the export of genomic data, creating a “dual-track” clinical environment.
References
- Morrison Foerster: BIOSECURE Act Signed into Law (Dec 2025)
- Baker McKenzie: Legal Impact of the 2026 NDAA/BIOSECURE Provisions
- Goodwin: Life Sciences Compliance under the 2026 NDAA