On May 5, 2025, a coalition of U.S. biotechnology companies announced the launch of the American Biotech Innovation Alliance (ABIA). ABIA states that it will “focus on a shared objective: to sustain and strengthen America’s leadership in biotech innovation.” ABIA will work to develop a new roadmap to support the biotech ecosystem. According to ABIA, leaders from across the U.S. biotech industry and research sectors will develop a national innovation strategy outlining the policy,...
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On April 27, 2026, the Organisation for Economic Co-operation and Development (OECD) published a blog item entitled “Biotech start-ups in Europe: Why does the EU lag behind competitors and what can policymakers do about it? ” According to the item, evidence shows that Europe still lags competitors in biotech start-up creation, patenting, and venture capital funding. OECD’s blog item “unpacks the gap and explores how agile regulation and smarter financing tools” can help European Union...
April 30, 2026
USDA’s New Guidance Portal Includes Biotechnology Guidance
The U.S. Department of Agriculture (USDA) announced on April 7, 2026, the creation of the USDA Guidance Portal, an online searchable, indexed database that contains guidance documents issued by USDA and its agencies that are currently in effect. Users can search all guidance documents in the library, or filter documents by date, agency (such as the Animal Plant Health Inspection Service (APHIS)), or topic (including biotechnology). USDA notes that the guidance documents lack the force and effect...
March 5, 2026
USITC Will Investigate State Support and Pricing Practices by Chinese Biotechnology Firms
The U.S. International Trade Commission (USITC) announced on February 26, 2026, that it is undertaking a factfinding investigation to examine Chinese state support and pricing practices in the biotechnology sector and assess how these practices may be affecting the market share and competitiveness of the U.S. industry. USITC states that it is instituting this investigation, “Impact on U.S. Industry of China’s State Support and Pricing Practices in the Biotechnology Sector” (Inv. No....
On January 29, 2026, Senator Tom Cotton (R-AR) introduced the Biosecurity Modernization and Innovation Act of 2026 (S. 3741) to establish a federal biosecurity framework. According to Cotton’s February 4, 2026, press release, the bill “will require gene synthesis providers screen their orders and customers for bad actors or dangerous pathogens, and will ensure that the U.S. government adopts a flexible and agile approach to biosecurity that will ensure American leadership in biosecurity.”...
On February 4, 2026, the National Security Commission on Emerging Biotechnology (NSCEB) announced the release of a fact sheet on biotechnology solutions for critical minerals. NSCEB notes that the United States is overly reliant on China for critical minerals. According to NSCEB, biotechnology “creates new paths to reduce our reliance on China by unlocking new sources of critical minerals right here in the United States.” NSCEB states that the recently-announced Project Vault and other...
February 4, 2026
OECD Paper Compares Regulatory Environments for Biotechnology and Biosolutions between the EU and United States
The Organisation for Economic Co-operation and Development (OECD) posted a working paper on January 30, 2026, entitled A comparison of the innovation and regulatory environments for biotechnology and biosolutions across the European Union and the United States. According to the authors, the working paper “strengthens the evidence base for biotechnology policymaking by examining two critical dimensions: innovation-enabling conditions and regulatory practices.” Focusing on the European Union...
January 29, 2026
NSCEB Paper Outlines Policy Options to Modernize Oversight of Biotechnology Products
The National Security Commission on Emerging Biotechnology (NSCEB) has published a January 2026 discussion paper entitled “Creating Clear Regulatory Pathways for Biotechnology.” According to the paper, biotechnology regulations in the United States are complex, resulting in a slow process, while regulations in China and other countries allow developers to move ahead more quickly. The paper notes that the regulatory system in the United States is “built on laws that predate biotechnology,...
Download a PDF of the Forecast 2026. Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our Forecast 2026. Our distinguished global team of chemical experts worked hard to summarize our collective best guess on what to expect in the New Year regarding global industrial, agricultural, and biocidal chemical regulatory and policy...
On December 15, 2025, the European Commission (EC) announced a legislative package that includes a proposal for a regulation to establish measures to strengthen the European Union’s (EU) biotechnology and biomanufacturing sectors (Biotech Act). The questions and answers (Q&A) on the Biotech Act note that the proposal is focused on health biotech, “although it also includes provisions on food and feed.” According to the Q&A, the Biotech Act would amend specific parts of EU health...