Industrial Policy & Trade Monitor· 2663 actions· ✨ 89 recent

On 16 December 2025 the European Commission adopted in Strasbourg the Proposal for a Regulation establishing a framework of measures for strengthening the Union's biotechnology and biomanufacturing sectors particularly in the area of health — the "European Biotech Act" (COM(2025) 1022 final). The proposal is the third axis of the EU's pharma/biotech industrial-policy stack alongside the Critical Medicines Act (filed: 2025-03-11-eu-critical-medicines-act-proposal) and the US Section 232 pharmaceuticals track (filed: 2026-04-02-us-section-232-pharmaceutical-proclamation), and is explicitly designed to keep biotech innovation, investment, and biomanufacturing capacity in Europe in the face of US/China competitiveness pressure. Core instruments: (1) statutory recognition for "Health Biotechnology Strategic Projects" (HBSPs) and "High-Impact" HBSPs eligible for accelerated permitting via a single national contact point, plus administrative/technical/ financial support; (2) regulatory sandboxes for novel biotech and biomanufacturing modalities; (3) a 12-month Supplementary Protection Certificate extension for qualifying biotech and advanced-therapy medicines; (4) targeted simplification of existing EU life-sciences acquis (clinical-trial timelines, risk-proportionate requirements); (5) an EU Health Biotechnology Investment Pilot co-developed with the EIB Group, paired with a EUR 10bn 2026-27 EIB-Commission financing initiative; (6) biosecurity safeguards including a list of "biotechnology products of concern" and mandatory built-in screening for benchtop nucleic-acid synthesis devices. A second tranche covering industrial biotechnologies and biomanufacturing outside health is expected later in 2026.

BIS amends the Export Administration Regulations (EAR) to implement decisions reached at the Australia Group (AG) November 2021 and March 2022 Virtual Implementation Meetings and the July 2022 AG Plenary in Paris. The rule adds four marine toxins to ECCN 1C351.d (brevetoxins, gonyautoxins, nodularins, palytoxin), removes cholera toxin from the controlled list, updates plant pathogen nomenclature in 1C354 to reflect current taxonomy, and clarifies biological equipment definitions in ECCN 2B352 (medical isolator exclusions and the term "disinfected"). The changes align US controls with the current AG Common Control Lists without introducing new country-specific restrictions.

BIS amends the Export Administration Regulations (EAR) to implement the decision adopted at the Australia Group (AG) Virtual Implementation Meeting of May 2021, creating new ECCN 2D352 to control software designed for nucleic acid assemblers and synthesizers (ECCN 2B352.j) that is capable of designing and building functional genetic elements from digital sequence data. The rule also amends ECCN 2E001 to capture technology for the development of 2D352-controlled software. Exports to most non-allied destinations require a BIS licence under CB Column 2 and AT Column 1, and the classification of 2D352 software as a critical technology triggers mandatory CFIUS filing requirements for qualifying foreign investment.

BIS amends the Export Administration Regulations (EAR) Commerce Control List to clarify the scope of ECCN 1C991 (vaccines, immunotoxins, and related medical products containing or derived from controlled biological agents) consistent with release and exclusion notes adopted at the June 2019 Australia Group (AG) Plenary Meeting. The rule adds clarifying language specifying which vaccines and medical products fall inside versus outside the ECCN 1C991 control perimeter, ensuring that routine vaccines produced by standard manufacturing methods are properly excluded. The changes align US controls with the Australia Group Common Control Lists without introducing new country-specific restrictions or license requirements.