Industrial Policy & Trade Monitor· 2662 actions· ✨ 89 recent

On 8 May 2026 China's National Health Commission released a public consultation draft proposing material amendments to the 2023 Implementation Rules for the Administrative Regulations on Human Genetic Resources, with a comment deadline of 7 June 2026. The draft narrows the statutory "foreign party" definition to a bright-line 50% equity/voting threshold (excluding VIE-structured entities), restricts "HGR Information" strictly to nucleic-acid sequence data (excluding clinical, imaging, and metabolic data), removes the separate Article 37 security-review requirement for sensitive HGR datasets, and introduces a same-day or next-working-day fast-track confirmation for international clinical trials not involving HGR information export.

Section 851 of the FY 2026 National Defense Authorization Act (P.L. 119-60), signed December 18, 2025, prohibits US federal agencies from procuring biotechnology equipment or services from designated "biotechnology companies of concern" (BCCs), and bars federal contractors from using such equipment/services in work performed under federal contracts, grants, or loans. The final enacted text ties initial BCC designations to DoD's existing §1260H Chinese-military-company list (which currently includes BGI and MGI, but not WuXi AppTec or WuXi Biologics) and directs OMB to designate additional BCCs within one year of enactment; operational prohibitions activate 60-90 days after FAR revision, with a five-year grandfather period for pre-existing contracts — enforcement is expected to begin in 2027-28. The legislation is the successor to H.R.8333 (118th Congress, House-passed September 2024 but stalled in the Senate before adjournment) and represents the first enacted US federal-procurement biotech-supply-chain-resilience statute.

China's State Council promulgated Order No. 818 on 28 September 2025 (effective 1 May 2026), establishing a comprehensive dual-track regulatory framework for biomedical new technologies — defined as techniques operating at the cellular or molecular level not yet clinically applied in China, covering cell therapy, gene editing, CAR-T, stem-cell, xenotransplantation, brain-computer interfaces, and nucleic-acid therapies. The regulation creates two parallel pathways: a traditional NMPA drug/device registration route and a new NHC-supervised clinical-research-to-commercialization track applicable to highly personalised or rare-disease therapies meeting staged safety and efficacy thresholds. Commercialisation under the NHC track is initially restricted to accredited Grade-3A medical institutions without full NMPA marketing approval, potentially accelerating patient access for qualifying technologies by 5–8 years relative to the standard registration pathway.

The Bureau of Industry and Security (BIS) amended the Export Administration Regulations (EAR) on 8 February 2022 to add 33 persons — all based in China — to the Unverified List (UVL) under EAR §744.15(c), on the basis that BIS could not satisfactorily complete end-use checks for these entities for reasons outside US Government control. Placement on the UVL bars exporters from using any EAR license exception when shipping controlled items to listed parties and requires exporters to obtain a certified UVL Statement from the entity or secure a BIS export licence. Sectors represented include semiconductor manufacturing equipment, optoelectronics, UAVs, specialty chemicals, and biotechnology.