Global Life Sciences & Healthcare Bulletin

Cross border

EU-India trade and technology partnership

On July 15, the EU and India held the third Trade and Technology Council (TTC) meeting in Brussels, strengthening cooperation on trade, technology and security. The partners agreed to launch negotiations on India's association to Horizon Europe by the end of 2026. Cooperation will expand on AI, semiconductors, quantum technologies, high-performance computing and 6G. Both sides also committed to strengthening resilient supply chains in pharmaceuticals.

Impact: Businesses operating between the EU and India in technology, digital services, AI and critical supply chains should monitor TTC outcomes closely. Expanded cooperation on AI, semiconductors, quantum technologies and 6G could create new investment and commercial opportunities. India's planned association with Horizon Europe may increase access to collaborative research projects and innovation funding. Businesses in pharmaceuticals should monitor developments affecting regulatory cooperation and trade opportunities.

UK-India Free Trade Agreement enters into force

On July 15, the UK-India Free Trade Agreement came into force. Under the agreement, 99% of Indian exports to the UK and 90% of UK exports to India will be duty-free or benefit from reduced tariffs. The deal covers a wide range of sectors, including automotive, manufacturing, consumer goods, creative industries and medical technology.

Impact: reduced tariffs on medical devices on UK exports to India should lower costs and improve market access for medtech firms. Indian pharmaceutical and generic drug manufacturers could benefit from greater access to the UK markets. The deal opens the potential for joint ventures, collaborative R&D, and some regulatory alignment between the countries. 

WHO Global Code of Practice on international recruitment of health personnel amended

On May 29, the World Health Organization (WHO) Member States adopted a resolution amending the WHO Global Code of Practice. The amendment covers the international recruitment of health personnel.

Key additions to the Code include:

• new provisions for health personnel recruited internationally as care workers
• applicability of Code recommendations during health emergencies
• encouragement of co-investment in health systems in source countries

An updated WHO Health Workforce Support and Safeguards List will be published later in 2026.

The amended Code allows countries to indicate willingness to permit active international recruitment. Countries may also request tailored support under the new provisions. The resolution reflects growing pressure on health systems from emergencies and funding constraints.

Impact: Although the Code is non-binding, it is politically influential and is increasingly referenced in national and regional regulatory frameworks. The amendment is relevant to healthcare employers, private care providers and staffing agencies. Businesses may want to consider reviewing international recruitment practices, assessing co-investment commitments to health systems in source countries, and engaging with national health authorities on domestic implementation of the amended Code.

World Health Assembly adopts resolution to strengthen pharmacovigilance

On May 22, the 79th World Health Assembly (WHA79) adopted a resolution to advance smart and efficient pharmacovigilance. The resolution supports strong and resilient health systems globally.

The resolution:

• calls on Member States to strengthen medicine and vaccine safety monitoring systems
• encourages the use of digital tools and real-world data for safety surveillance
• highlights the importance of timely safety signal detection and risk communication
• emphasizes lessons from recent health emergencies for pharmacovigilance systems
• calls for improved regulatory capacity and workforce development
• addresses efforts to counter disinformation on medicine safety

The resolution builds on WHO's Global Smart Pharmacovigilance Strategy. It supports efforts to advance universal health coverage.

Impact: The resolution imposes no direct legal obligations on businesses, but signals global political commitment likely to shape future regulatory frameworks. It is relevant to pharmaceutical manufacturers, medical device businesses and vaccine producers. Regulatory affairs professionals operating globally should also take note.

Businesses may want to consider reviewing pharmacovigilance systems, assessing readiness to integrate real-world data and digital tools into surveillance, and strengthening risk communication procedures as part of post-market surveillance obligations.

Asia

China: Revised drug clinical trial rules take effect

From September 1, revised good practice rules for drug clinical trials take effect. Announced June 8 by the National Medical Products Administration, they replace the previous 2020 framework. The revision adopts core principles on good practice from the International Council for Harmonization’s guideline E6(R3), including quality by design and risk proportionality. It also introduces a standalone chapter on data governance covering audit trails, electronic signatures, and system validation. Sponsor accountability for outsourced trial activities is strengthened. Ethics committees also gain expanded oversight of safety events, protocol deviations, and continuing review.

Impact: Electronic data capture systems must now meet stricter validation, audit trail, and access control standards. Informed consent materials may need updating, particularly for vulnerable trial participants. Trial budgets may need adjustment to cover free investigational product supply and participant compensation requirements. 

China: Five-year plan for universal healthcare security

On August 19, the National Healthcare Security Administration announced its 15th Five-Year Plan for universal healthcare security. The plan outlines 26 measures across eight areas covering the period 2026 to 2030. It aims to build a multi-tiered system that is universal, fair, and financially sustainable. Eight headline targets are set, including maintaining 95% enrollment and expanding long-term care insurance nationwide. The plan introduces a self-assessment pricing regime for newly launched innovative drugs. It also mandates building a unified national pharmaceutical procurement market. Insurance catalog management will broaden to cover drugs, consumables, and medical service items together. Oversight will tighten up, with AI-driven monitoring and mandatory traceability code scanning.

Impact: Innovative drug manufacturers could benefit from early-stage price stability tied to demonstrated clinical value. Products lacking clear differentiation face intensified price pressure through centralized volume based procurement. Companies should prepare for a unified national drug listing and procurement platform replacing fragmented regional systems. Real-world evidence strategies could take on greater importance to sustaining reimbursement and pricing over product lifecycles.

China: Medical insurance pricing update

On July 9, the State Council reported National Healthcare Security Administration (NHSA) measures on medical insurance coverage and price regulation. Authorities launched a nationwide initiative to regulate prices of medicines and medical consumables. Officials said prices for 33 types of consumables, including defibrillators, heart valves and embolic protection devices had been reduced to more reasonable levels.

Impact: Pharmaceutical and medtech companies selling reimbursed products should expect continued pressure on pricing, procurement and access strategies, especially for high-value consumables. They may want to assess exposure across medical consumables categories.

China: Classification rules for cell and gene therapies

On July 3, the Center for Drug Evaluation, under the National Medical Products Administration, published two technical guidelines effective immediately. The first covers cell therapy medicinal products, and the second addresses gene therapy medicinal products. Together, they establish a formal framework for categorizing advanced therapies into distinct regulatory classes. Products are now classified based on their material basis and primary mechanism of action. Where the active substance is a cell, the cell therapy framework generally applies. Where in vivo delivery of genetic material drives the therapeutic effect, the gene therapy framework governs. The guidelines address a growing regulatory gap as platforms such as CAR-T and in vivo gene editing increasingly blur traditional category boundaries.

Impact: Businesses with cell or gene therapy assets should review each product's classification against the new criteria. A mismatch between classification could cause costly submission delays. This risk is highest for hybrid platforms and products categorized differently in other jurisdictions. Companies would be advised to prepare a classification memorandum identifying procedures.

South Korea: Medical Device Act amendments take effect

On July 1, amendments to the Medical Device Act (Act No. 21263) took effect. A key change is a clearer legal basis for manufacturing and quality management system (QMS) conformity assessments. Other changes include the issuance, renewal, suspension, and cancellation of conformity recognition. It also strengthens inspection and enforcement powers and introduces requirements relating to technical documentation review bodies and quality management assessment organizations. Additional measures address market transparency and oversight of medical device sales practices.

Impact: Manufacturers and importers should obtain conformity recognition for their manufacturing and quality management systems before approval related activities where required. Manufacturers should ensure compliance with QMS assessment requirements and maintain records to avoid corrective orders or cancellation of conformity recognition.

Singapore: Clinical trials guidance update

On June 23, the Health Sciences Authority (HSA) updated its clinical trials guidance page. This consolidates guidance on trial submissions, conduct, good clinical practice compliance (GCP), safety reporting, investigational products, and public-health emergency procedures. It also confirms International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. ICH E6(R3) Annex 2 is applicable from January 1, 2027.

Impact: Trial sponsors, contract research organizations, and trial sites may want to review protocols, standard operating procedures, consent processes, product handling, and GCP training. Businesses should assess gaps against updated HSA guidance and ICH E6(R3) expectations. Early remediation could reduce approval delays, safety-reporting risks, and operational disruption.

China: Outbound investment regulation

On June 1, the State Council announced a Regulation on Outbound Investment (Order No. 837), effective July 1, 2026. The Regulation establishes a comprehensive framework governing overseas investment by Chinese entities and individuals. It establishes a new outbound investment security review system. It embeds export control rules into outbound investment oversight. The Regulation also authorizes countermeasures against foreign discriminatory restrictions on Chinese investors.

Impact: Businesses investing overseas should review existing compliance frameworks. Individual investors are now formally subject to outbound investment regulation. Outbound transfers of restricted technology, data, or services face stricter controls. Businesses in AI, semiconductors, and biotech face heightened scrutiny on cross-border knowledge flows. Countermeasure provisions may affect foreign entities restricting Chinese investors.

South Korea speeds up medical product reviews

On June 1, the Ministry of Food and Drug Safety’s (MFDS) new expedited approval and review process took effect. The medical product approval plan covers new drugs, biosimilars, and innovative medical devices. The plan targets approvals within 240 days. MFDS will add 195 review staff, use pre-submission meetings, and give rolling feedback. The changes aim to expand patient access and strengthen the country’s bio-health sector.

Impact: Businesses should assess eligibility for the new pathways and prepare dossiers against MFDS checklists before filing. Faster feedback may improve product launch planning. However, they should align internal procedures, plan earlier dossiers and agency interactions, as weak submissions could still delay approval.

Europe

EU: Legal challenge to EU Wastewater Directive impacting pharma

On September 3, EU’s Advocate General issued their opinion recommending that the Court of Justice annul provisions of the Urban Wastewater Treatment Directive requiring pharmaceutical and cosmetics producers to finance at least 80% of quaternary wastewater treatment costs. The Advocate General found that EU institutions failed to properly assess the scientific evidence underlying the cost allocation, identifying flaws in toxic load methodology and insufficient evaluation of other micropollutant sources.

Impact: If the Court follows the Advocate General's recommendation, companies could avoid disproportionate financial burdens that could otherwise disrupt European supply chains, risk medicine shortages, and undermine research and manufacturing capacity.

EU: Packaging and packaging waste rules start to apply

On August 12, new rules under the Packaging and Packaging Waste Regulation started applying across the EU. Food contact packaging containing PFAS or heavy metals above specified limits can no longer be sold in the EU market. The regulation also introduces greater harmonization across Member States. Definitions of manufacturers, importers, distributors, suppliers and producers responsible for extended producer responsibility are now aligned. Certain markings and information are now required on packaging. These requirements help identify packaging manufacturers or importers. The measures applying from August 2026 are part of a broader implementation timeline. Additional requirements will take effect gradually. Most obligations will become applicable from 2030. Additional requirements will be introduced in stages until 2040.

Particularly regarding medicines, primary packaging (vials, ampoules, blisters) must comply with the strictest GMP standards, so materials compliant with the regulation cannot replace the current one if it compromises product safety.

The regulation acknowledges this tension and allows a limited exemption where a material change would endanger the medicinal product's safety or efficacy. The exemption must be explicitly justified in the technical documentation, a generic reference to "pharma requirements" is insufficient.

Impact: Businesses across all sectors, including pharmaceuticals, that use packaging should prepare for further obligations phased in from 2028 and 2030.

Businesses should consider:

• checking contact packaging for PFAS and heavy metals compliance
• reviewing packaging labelling and marking requirements
• planning ahead for recyclability, reuse targets, and format restrictions from 2030

Eversheds Sutherland Packaging and Packaging Waste Regulation Compliance Guide

EU: Scaleup Europe Fund launch update

On August 4, the European Commission completed the final legal steps to establish the Scaleup Europe Fund. The fund has a target size of €5 billion. The fund will invest directly in high growth EU technology companies. Strategic tech areas specifically targeted for investment include AI, quantum technologies, biotechnologies, medical technologies and clean technologies. The EU's investment is supported by the Horizon Europe program. The fund is part of the European Innovation Council Fund.

The first investments are expected in the coming weeks.

Impact: Technology businesses at the scale-up stage in AI, quantum, biotech and cleantech should assess investment opportunities arising from the fund. The fund aims to provide growth capital so EU businesses can expand without seeking funding outside EU. It may also create co-investment opportunities for venture capital and private equity businesses.

EU: AI Act enforcement and transparency rules apply

On July 31, the European Commission announced that enforcement of the AI Act begins on August 2, 2026. The AI Office and national authorities will oversee enforcement. The first obligations focus on transparency requirements for AI systems. Chatbots must disclose AI interaction, deepfakes must be labelled, and AI generated content must include machine readable markings. Breaches of Article 50 (transparency obligations) may result in fines of up to EUR 15 million or 3% of global annual turnover. The AI Omnibus proposal has deferred rules for high-risk AI systems until December 2, 2027, and rules for high-risk AI systems integrated into regulated products to August 2, 2028.

Impact: Businesses deploying AI systems in the EU should ensure compliance with the new transparency requirements. Businesses using chatbots, generative AI tools, or content generation systems must disclose AI interactions and label AI generated or manipulated content. Existing systems benefit from a transitional period until November 2, 2026 for machine readable content markings.

Eversheds Sutherland article

EU: Digital Omnibus on AI in force

The EU’s Digital Omnibus on AI entered into force on July 27, amending the AI to ease compliance and administrative burdens, extending timelines, expanding testing and experimentation opportunities, and providing greater legal clarity. Key changes include a transition period for transparency obligations on existing generative AI systems until November 2026, and mandatory registration of certain AI systems exempt from high-risk status. The AI Omnibus proposal has deferred rules for high-risk AI systems until December 2, 2027, and rules for high-risk AI systems integrated into regulated products to August 2, 2028.

The Omnibus also introduces stricter rules for processing sensitive personal data for bias monitoring, extends compliance flexibilities to small mid-cap companies, clarifies links with product safety laws, expands regulatory sandboxes, and strengthens enforcement powers for the EU AI Office.

Impact: The new implementation timetable and streamlined rules will be welcomed by businesses who should now have the benefit of supporting technical standards and guidance before compliance obligations take effect.

EU: Foreign Subsidies Regulation Review published

On July 14, the European Commission (EC) published its first review of the Foreign Subsidies Regulation (FSR). The review concluded that the FSR remains necessary and effective in addressing market distortions caused by foreign subsidies, and its objective of maintaining a level playing field remains widely acknowledged and relevant. The EC found that notification systems are functioning but could be simplified and streamlined, noting concerns about complexity and administrative burden raised by stakeholders. It plans targeted adjustments, including higher notification thresholds and reduced reporting requirements for low-risk cases. Draft reforms are expected in autumn 2026, with adoption planned in 2027.

Impact: Businesses involved in EU mergers, acquisitions or large public procurement procedures should continue monitoring FSR compliance requirements closely. The EC also retains ex officio powers to investigate potentially distortive foreign subsidies in any market situation. Businesses receiving foreign financial contributions may remain subject to scrutiny during transactions and procurement bids but can anticipate streamlined procedures.

Particularly, companies should be attentive to the concentration notification thresholds (EU turnover of at least EUR 500 million and aggregate foreign subsidies exceeding EUR 50 million over the preceding three years). Companies involved in such deals should ensure robust foreign subsidies tracking processes are in place.

Additionally, the public procurement chapter applies to high-value contracts (estimated value of at least EUR 250 million, or EUR 125 million for lot-based procurement) where tenderers have received aggregate FFCs of at least EUR 4 million per third country over three years. This is directly relevant to large-scale procurement of medical devices, hospital equipment, diagnostic systems or pharmaceutical supply contracts by public health authorities.

Businesses should consider reviewing processes for identifying and tracking foreign financial contributions across group entities.

EU: EDPB anonymization and generative AI guidance

On July 7, the European Data Protection Board (EDPB) adopted Guidelines 02/2026 on Anonymization for public consultation. The guidelines clarify when data qualifies as anonymous under the GDPR. They introduce three assessment criteria: No Record Isolation, No Linkage, and No Inference. On July 8, the EDPB announced further guidance on anonymization and web scraping for generative AI. It also adopted the final version of its blockchain guidelines. The anonymization consultation is open until October 30, 2026.

Impact: International technology, AI, life sciences and data companies should reassess anonymization, scraping, and blockchain compliance positions. The guidance raises the bar for demonstrating that data is truly anonymous. Generative AI developers face particular scrutiny on web scraping practices. The three criteria (No Record Isolation, No Linkage and No Inference) will need to be applied to clinical trial datasets, patient registries, electronic health records and other health data assets. Given the high dimensionality and sensitivity of health data, achieving genuine anonymization may be more challenging than for other data categories. Companies should note that the anonymization process itself constitutes processing of personal data requiring a legal basis under Article 6 GDPR and, where special category data is involved, a derogation under Article 9(2) GDPR.

UK

UK: Regulatory position on microbiome-based medicines

On August 18, the Medicines & Healthcare products Regulatory Agency (MHRA) published a position paper on microbiome-based medicinal products (MBMPs). The paper confirms that MBMPs fall within the existing UK medicines regulatory framework. Existing legislation under the Human Medicines Regulations 2012 applies. Products may be regulated as biological medicinal products or, where criteria are met, as advanced therapy medicinal products. The MHRA encourages early developer engagement to clarify requirements and accelerate development pathways. 

Impact: Businesses interested in developing MBMPs may want to initiate early scientific advice discussions with the MHRA before committing to pivotal investment decisions. Key compliance challenges include product characterization, manufacturing controls, batch variability, and antimicrobial resistance risk. No new MBMP-specific legislation is proposed, so firms must navigate existing biological medicines rules.

UK: AI regulatory sandbox launched

On July 30, the Medicines & Healthcare products Regulatory Agency (MHRA) opened expressions of interest for the 'London Region I' regulatory sandbox. It is open to AI medical device manufacturers and London-based NHS providers. Selected participants can test AI-enabled devices in real world NHS settings under MHRA oversight to generate safety and effectiveness evidence.

Impact: AI medical device developers with UK deployment plans should evaluate whether London-based real world testing can support market access, evidence generation and post-market safety strategies. Real world evidence plans will need to align cybersecurity, clinical safety and governance materials.

UK: Life sciences delivery plan update

On July 9, the Government published its Life Sciences Sector Plan: One Year On update. It reports progress by Department for Science, Innovation and Technology, Department for Business and Trade, Department of Health and Social Care, and the Office for Life Sciences. Key developments include £3 billion of investment, faster clinical trial set-up, and regulatory and market-access reforms. The update tracks delivery on the aim of making the UK Europe’s leading life sciences economy by 2030.

Impact: Life sciences businesses should treat the plan as a strategic signal for trials, health data, medtech reliance, manufacturing incentives and market-access reforms. Businesses may want to reassess domestic strategies as programs move from design to delivery. Clinical trial sponsors could take advantage of possible further changes in routes to market.

UK plans faster route to market for innovative businesses

On July 8, the Government announced that the Regulation for Growth Bill will create statutory regulatory sandbox powers, enabling businesses to test innovative products and services under regulatory oversight. The reforms aim to reduce regulatory barriers, accelerate commercialization and support investment in sectors such as AI, life sciences and autonomous technologies. New guidance outlines eligibility, safeguards and benefits of participation. The proposals are also highlighted in the July Regulation Action Plan Progress Report, which states that regulatory reform is progressing well. Priority sectors include digital technology, advanced manufacturing, aerospace, clean energy and life sciences, alongside measures to improve regulatory accountability and performance oversight.

Impact: For innovative sectors such as AI, life sciences, advanced manufacturing, these reforms could mean faster approvals, lower compliance burdens, and easier market entry. Creating a potential quicker route from testing to commercial deployment.

UK: Regulatory path planned for life sciences innovation

On July 2, the Medicines and Healthcare products Regulatory Agency (MHRA) Chief Executive set out a policy direction. It argues that regulation should help lead, rather than follow, innovation in life sciences. A central element of the announcement is a proposed new rare disease framework that would replace the traditional three-phase clinical trial and licensing pathway with an Investigational Marketing Authorization model. This aims to attract biotech, orphan drug, and advanced therapy businesses with a business friendly regulatory environment for novel products.

A National Commission report is due in autumn 2026. Its findings could reshape approval requirements for novel, non-pharmaceutical products.

Impact: Life sciences companies may want to prepare for faster regulatory pathways. The rare disease framework could allow firms to pursue earlier market access through phased evidence generation. Sponsors should reassess clinical development plans to align with this iterative authorization model. Businesses should build flexible compliance frameworks capable of adapting to evolving evidentiary standards.

UK launches Supply Chain Centre to strengthen resilience

On June 17, the Department for Business and Trade established a new Supply Chain Centre to improve the UK's supply chain resilience, support economic growth and respond to disruption caused by geopolitical tensions, climate risks and changing trade dynamics.

The Centre has identified 36 categories of goods key to UK growth sectors and will provide businesses with guidance, risk intelligence and support on supply chain resilience. It will also lead a 14-point action plan covering risk monitoring, international partnerships, crisis response and business engagement.

Impact: Businesses could expect greater government focus on supply chain risk management and may benefit from new intelligence, funding opportunities and support to identify vulnerabilities and diversify sourcing.

UK: Evidence base for AI healthcare regulation

On June 11, the Medicines and Healthcare products Regulatory Agency (MHRA) published the National Commission into the Regulation of AI in Healthcare Research and Engagement Report. This consolidates findings from research, stakeholder engagement, surveys, evidence reviews, and regulatory activity. It draws on input from patients, the public, healthcare professionals, industry, and system partners. Key themes include strong public support for ongoing post-market monitoring of AI technologies. Stakeholders also emphasized the need for transparency, accountability, and human oversight. The Report does not set out final policy or recommendations. Instead, it forms the evidence base for the Commission's final recommendations, expected this year.

Impact: Companies developing or deploying AI-enabled medical technologies should anticipate a more adaptive, lifecycle-based regulatory framework. The Commission's final recommendations will likely require continuous real world monitoring of AI performance after market entry. Businesses should prepare for clearer liability allocation across the AI supply chain. Lower risk AI tools may benefit from streamlined approval routes, while higher risk applications could face greater scrutiny.

UK supports industry to embrace AI

On June 8, the Government published its interim response to the AI Champions’ sector adoption plans. They cover professional and business services, life sciences, manufacturing, energy, creative industries and technology. The plans highlight common barriers to AI adoption, including limited use cases, skills shortages, cost pressures and regulatory uncertainty. To address these challenges, the Government will support increased AI skills funding, workforce development, innovation pilots and industry-led programs focused on skills, data readiness and regulatory clarity. The plans will help shape Industrial Strategy sector plans and future AI policy. The Government has also launched the AI Economics Institute to analyze AI’s impact on productivity, labor markets, businesses and income distribution, and to inform future policymaking.

Impact: These announcements indicate that businesses could expect increased support, funding opportunities and practical guidance to help deploy AI at scale. The Government's emphasis on sector-specific adoption, workforce skills and regulatory certainty should help organizations move beyond experimentation and unlock productivity and growth benefits.

UK: Health research regulator publishes AI action plan

On May 28, the Health Research Authority (HRA) launched a two year plan (2026-2028) to support the safe and trusted use of AI in UK health and social care research. The plan focuses on three priorities: supporting safe innovation, providing greater clarity for researchers, and maintaining public confidence in AI enabled research. It forms part of the HRA's wider strategy and aligns with the Government's AI Opportunities Action Plan.

Impact: For businesses developing or deploying AI in healthcare and life sciences, the plan signals continued regulatory support for AI innovation, alongside an increased focus on transparency, governance and public trust.

US

US: Cell and gene therapy development guidance finalized

On August 19, 2026, the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research finalized industry guidance on developing cellular and gene therapy products. The document addresses frequently asked questions spanning regulatory review, manufacturing controls, nonclinical studies, and clinical trials. It was created under the Prescription Drug User Fee Act VII commitment to support the Office of Therapeutic Products' engagement with sponsors. The guidance consolidates recommendations previously shared through town halls and stakeholder interactions.

Impact: Although the guidance contains nonbinding recommendations sponsors may want to ensure they are aligned with it to minimize any issues with regulatory risk during product reviews. Developers should review the document alongside the recent Center for Biologics Evaluation and Research guidance on chemistry, manufacturing, and controls flexibilities and genome editing.

US: Federal ban on funding for certain gain-of-function research

On July 28, the Administration released the Government Policy for Stopping High Risk Life Sciences Research. Issued pursuant to Executive Order 14292, the policy prohibits federal funding for "dangerous gain of function" (DGOF) research. DGOF is identified in the policy as research with a biological agent that seeks or risks achieving outcomes such as enhanced transmissibility, pathogenicity, or immune evasion with potentially significant negative societal consequences. The policy also bans funding for "international research of concern" involving designated countries or entities. It replaces prior oversight frameworks with a broader, risk based model. Potential DGOF research may still receive funding, but only after independent third party review. Vaccine, therapeutics, and medical countermeasure development remains permitted under enhanced safeguards.

Impact: Life sciences companies and research institutions receiving federal funding face substantial new compliance obligations. Institutions must designate an Institutional Contact for DGOF Research and establish a five member Institutional Review Entity by January 2027. Principal investigators must certify in writing whether proposed research constitutes DGOF or potential DGOF before submission. Institutions have to identify and annually report privately funded DGOF related research conducted within their organization. Noncompliance could trigger funding revocation, up to five years of federal funding ineligibility, and potential False Claims Act exposure. International collaborations will require heightened scrutiny.

US: Tariffs imposed on 60 economies over forced labor

On July 23, the Administration issued a memoranda outlining new tariffs of 10% and 12.5% on imports from 60 trading partners. The action was taken under Section 301 of the Trade Act of 1974. Authorities said the tariffs address failures to prevent goods made with forced labor from entering supply chains. The measures replace a temporary global tariff that expired the same day. The new duties cover most imports but include exemptions for products such as oil, gas, fertilizers, aircraft, critical minerals, and goods already subject to national security tariffs. The Administration indicated further trade action may follow through a separate investigation into industrial overcapacity.

Impact: Businesses importing into the country should assess whether products are subject to the new tariff rates or available exemptions. Companies should review supply chains and strengthen due diligence on forced labor compliance. Importers may face increased costs, pricing pressures, and contractual risks where goods are newly affected. Companies with cross-border supply chains should evaluate sourcing alternatives and update trade compliance strategies.

US: Proposed rule to simplify selected drugs registration

On July 13, the Food and Drug Administration (FDA) published a proposed rule in the Federal Register. The rule would amend drug establishment registration and listing requirements. It applies to two groups, distributed manufacturers and some foreign establishments. The FDA wants to create a streamlined registration pathway for distributed manufacturing establishments operating across multiple sites. This would let a single distributed manufacturer register as one establishment despite using separate hubs and units.

Separately, the FDA proposes new registration and listing rules for foreign establishments not currently covered under existing regulations. The changes aim to improve FDA's visibility into the global drug supply chain.

Comments on the proposal close on September 11, 2026.

Impact: Drug manufacturers using distributed or point-of-care models should review the proposed framework. Companies operating multi-site manufacturing hubs could benefit from simplified registration. However, new recordkeeping and equivalency documentation requirements could increase compliance burdens.

Foreign operations previously outside FDA's registration and listing regime should assess their exposure. Businesses should evaluate current supply chain structures against proposed definitions for hubs, units, and equivalency standards. Foreign relocations would require 120 days' notice under the proposal.

US: New initiative aims to establish clinical trial leadership

On June 22, the Department of Health and Human Services (HHS) announced 'Operation TrialBlazer.' This coordinated, department-wide initiative aims to establish leadership in clinical research. It aims to reverse a growing migration of early stage trials overseas. The initiative spans multiple agencies. Key measures include shortening timelines from drug identification to first-in-human trials and clarifying that one well designed late stage trial may suffice for drug approval. The HHS Office of Inspector General also issued a Request for Information on barriers to domestic clinical research.

Impact: The draft guidance on single trial approval pathways could reshape drug development strategies and reduce costs. Organizations using electronic health records should anticipate new interoperability requirements linked to trial recruitment. Contract research organizations and academic medical centers could face pressure to streamline trial activation processes. Companies with overseas trial footprints should evaluate whether shifting capacity back to the US offers a regulatory or competitive advantage.

US: Executive Order on AI security and innovation

On June 2, the Administration published an Executive Order (EO) promoting AI innovation and security. The EO sets a framework to support AI development while addressing national security risks and cyber threats. It directs federal agencies to strengthen cyber defenses across government systems and expand AI-enabled security tools. It also establishes a voluntary cybersecurity clearinghouse to help identify and fix software vulnerabilities. The EO introduces a benchmarking process for advanced AI models and encourages developers to cooperate with government testing before release. It also prioritizes enforcement against criminal misuse of AI.

Impact: Businesses should treat the EO as a signal of increased federal focus on AI-enabled cybersecurity. Those in regulated sectors may benefit from expanded federal support for cyber defenses. More broadly, companies should monitor future guidance on benchmarking, liability and cooperation frameworks, as these may shape emerging compliance expectations.

Further reading

Commercially connected - August 2026

New electronic disclosure rule for group health plan notices proposed by DOL

EU Design Protection Enters the Third Dimension

Hong Kong: Actions to take under critical infrastructure cybersecurity regime

Global Sustainability & ESG Insights - July 2026

FTC and states file enforcement action against digital healthcare provider challenging adtech & subscription practices

Global AI Regulatory Update - July 2026

When must advertisers disclose the use of AI?

China: What the Five-Year Plan means for business

Co-authored by Westley Trimble, Uendi Barreti, Jon Botham, Paola Paccani (Knowledge)