Global Life Sciences & Healthcare Bulletin

Cross Border

EU approves key parts of the EU-US trade deal

On May 20, the European Parliament and Council reached a provisional agreement on implementing tariff measures as part of the EU-US trade deal. The agreement operationalizes the EU-US Joint Statement, focusing on removing EU tariffs on US industrial goods and granting preferential access. Safeguards have also been strengthened, enabling the European Commission to step in if imports from the US surge by more than 10% year-on-year.

The regulation includes monitoring requirements, a reinforced suspension clause, and a sunset provision ending application in 2029.

The provisional agreement must be endorsed and formally adopted by both institutions. Following adoption, the regulations will be published in the Official Journal and enter into force the next day.

Impact: The approval of these tariff measures marks an important step towards securing the EU-US trade deal. It will promote greater predictability for EU exporters with regards US tariffs, and will also promote greater US trade to the EU thanks to trade-barrier reductions.

South Korea-Singapore free trade agreement upgrade negotiations

On April 28, negotiations were announced on an upgrade to the South Korea-Singapore bilateral free trade agreement (FTA). Discussions cover supply chains, the green economy, aviation services, and trade facilitation. Ministerial talks also addressed broader cooperation, including energy, biotechnology, pharmaceuticals, and plurilateral trade initiatives. Discussions also addressed investment opportunities, cross-border e-commerce, and energy security.

Impact: The announcement could be seen as a response to global supply chain tensions, strengthening economic ties between the two nations. An expanded FTA scope may improve market accessing key sectors including pharmaceuticals.

EU and South Korea deepen trade and technology cooperation

On April 17, the EU and South Korea agreed to deepen cooperation under their Free Trade Agreement framework.

The partners held their first Strategic Dialogue on trade, supply chains, and technology, strengthening geo‑economic cooperation. They endorsed the final text of an EU‑Korea Digital Trade Agreement, to be signed later in 2026.

Discussions highlighted the strong trade agreement benefits, including growing goods trade and significant bilateral investment flows. Both sides advanced work on the mutual recognition of electronics. The dialogue established cooperation on economic security, critical raw materials, advanced technologies, and batteries.

Impact: Discussions remain at an early stage, and clearer expectations for businesses will emerge as negotiations advance. The direction suggests enhanced cooperation could support new opportunities in advanced manufacturing.

UK-US pharmaceuticals deal update

On April 2, the UK‑US pharmaceutical partnership was finalized. Announced in December 2025, it removes tariffs and reforms pricing to improve medicines access and boost investment.

UK pharmaceutical exports to the US will face 0% tariffs for at least three years. Changes to National Institute for Health and Care Excellence (NICE) evaluation rules from March 31, 2026 expand approval of treatments that might previously have been rejected on cost grounds.

The Voluntary Scheme for Branded Medicines Pricing, Access and Growth rebate rate is capped at 15% until December 31, 2028. This aims to improve pricing predictability.

The partnership aims to incentivize companies to launch innovative treatments earlier. A joint UK‑US taskforce will support innovation, with pilot schemes expected from September 2026.

Impact: Pharmaceutical businesses could benefit from early launches due to tariff-free exports and improved pricing frameworks. Investment in UK-based research and manufacturing could benefit from government incentives. This could boost the UK's role in pharmaceutical supply chains. US pharma could benefit from higher NHS spending and revised NICE thresholds.

Asia 

China: Drug trial data protection measures

On May 15, the National Medical Products Administration (NMPA) issued Implementation Measures for Drug Trial Data Protection (No. 47 2026). This aims to support drug innovation and strengthen regulatory protection frameworks.

The measures allow applicants to submit data protection requests alongside drug registration applications. Qualifying products receive protection periods of six, four, or three years, depending on innovation level.

During protection, regulators will not approve applications relying on protected data without the holder’s consent. Applicants must request protection when filing for marketing authorization.

Generic applicants may submit applications one year before expiry, but approval is delayed until protection ends.

Exceptions apply for public health needs and where independent data is used.

Impact: Health and life sciences businesses may want to assess eligibility and submit data exclusivity requests. They may need to reassess their patent and data protection strategies. Early action could help secure market exclusivity for their most innovative products.

China: Updated drug advertising rules

On May 15, the State Administration for Market Regulation (SAMR) issued draft measures to strengthen drug, health foods, and medical product advertising oversight and invited public comments.

The draft revises existing rules, adding 13 articles and amending 27 across 48 provisions. It plans to tighten content controls, ban claims or opinions beyond approved product instructions to prevent misleading consumers. The proposed rules aim to enhance disclosure requirements and expand supervision to online and live‑stream advertising channels.

Some factual product displays on company platforms may no longer require prior advertising review. The draft simplifies approval procedures, validity periods, and rules for digital elements such as QR codes. SAMR plans to refine and implement the measures after consultation.

Impact: In anticipation of the new rules companies should ensure advertising strictly aligns with approved product instructions and avoid unverified claims. They may need to review existing processes, especially in regard to the popular live streaming market.

China: New framework for biomedical innovation in force

On May 1, Order No. 818, Regulations on Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies came into force. This was issued in September 2025.

The Order establishes a dual-track system for oversight, consisting of a clinical research filing stage and a subsequent clinical translational application approval stage. It allows certain therapies to be commercially applied in hospitals without traditional National Medical Products Administration (NMPA) drug approval. Qualified hospitals may charge for treatments once clinical translation approval is granted. However, fees remain prohibited during clinical study stages under strict patient protection rules.

It could benefit personalized therapies such as gene editing and cell therapies. The regulation aims to accelerate patient access, retain domestic innovation, and strengthen regulatory position. Foreign investment restrictions apply.

Impact: The Order provides a possible new pathway for advanced therapies and possible faster routes to market. Strong due diligence, patient protection and data compliance frameworks are essential. Foreign life sciences companies will have to enter joint venture or licensing models to address investment restrictions.

South Korea: First domestic CAR‑T gene therapy approved

On April 29, the Ministry of Food and Drug Safety granted full manufacturing and sales approval to the country’s first domestically developed Chimeric Antigen Receptor T-cell (CAR‑T) therapy.

It exempts a Phase 3 trial, instead requiring long‑term follow‑up and post‑approval risk management. The decision reflects expedited regulatory pathways and coordinated government research and development support under the country’s advanced biopharmaceutical framework.

Impact: The approval marks a significant step for the country’s biotechnology sector. Domestic biopharmaceutical businesses could see further expedited review and trial exemptions for novel therapies. It could pave the way for further CAR-T technological advancements. Companies in this field should take advantage of the Government’s drive to be more self-reliant on novel therapies.

China: New industrial and supply chain security rules

On April 7, the State Council published new Regulations on Industrial and Supply Chain Security, taking effect immediately. They consolidate export controls, anti-sanctions rules, and other tools into a unified national security framework.

They establish a national coordination mechanism involving multiple central and local government bodies. Authorities will identify key sectors and dynamically adjust lists covering critical materials, technologies, equipment, and products. The framework expands scrutiny to commercial conduct that authorities believe could affect supply chain stability.

Impact: The Regulations reflect a shift toward proactive deterrence of commercial behavior seen as posing a supply chain risk. Manufacturers’ supply chain decisions could face greater regulatory scrutiny, including audits and data collection. Businesses should ensure they comply with the regulations on the transfer of supply chain data across borders. Multinational companies using active pharmaceutical ingredients should ensure their China related supply chain structures are compliant.

China: New trade secret protection regulation

On February 24, the State Administration for Market Regulation (SAMR) issued the Trade Secret Protection Regulations (Order No 126). Effective from June 1, 2026, the rules define trade secrets and set clear standards for confidentiality measures. They list unlawful methods of obtaining or using trade secrets. Market regulators gain expanded powers to investigate and penalize infringements. Penalties increase for severe or repeat violations. Acceptable actions outlined in the rules include independent research, reverse engineering, and disclosures for public interest. Rights holders may report suspected infringements and must provide preliminary evidence. Authorities must protect confidential information during investigations. These regulations aim to improve fairness, competition, and commercial innovation across industries.

Impact: Businesses should improve internal controls and adopt appropriate technical and managerial safeguards. They should ensure their supply chain operations incorporate trade secret safeguarding and do not expose them to any violations of the regulation.

Europe 

EU: Critical medicines act update

On May 12, the Council and Parliament reached a provisional agreement on the Critical Medicines Act. This aims to strengthen resilience to medicine shortages, diversify supply chains, boost EU manufacturing, and enable joint procurement. It also plans to introduce resilience criteria in public procurement, including an ‘EU preference’ for locally produced medicines. The Act forms part of the EU’s broader pharmaceutical legislation reform package, which includes the proposed revision of the general pharmaceutical framework.

The provisional agreement will have to be endorsed by the Council and the Parliament. It will then formally be adopted. No legal obligations arise until the regulation is formally agreed and adopted.

Impact: Life sciences companies should proactively assess their production and distribution capacity within the EU, identify strategic projects eligible for incentives, and adjust their public procurement plans and national stock management accordingly. This forward‑looking preparation will help them maximize the benefits of the regulation while mitigating risks linked to potential shortages of critical medicines.

EU agrees to simplify AI Act rules

On May 7, the Council of the EU and the European Parliament announced a deal to simplify the AI Act (Regulation (EU) 2024/1689), the world’s first comprehensive legal framework for Artificial Intelligence, which entered into force on August 1, 2024.

Key elements of the agreement include:

• high-risk AI timelines: application of rules is delayed, with new dates set for December 2027 or August 2028
• SMEs and small mid-caps: certain regulatory exemptions are extended to small mid-cap companies to reduce compliance burdens
• transparency obligations: the grace period for AI-generated content transparency is reduced to three months, with a deadline of December 2, 2026
• data and bias testing: processing of sensitive personal data is allowed only where strictly necessary for bias detection and correction

The agreement must still be formally endorsed by both the Council and the Parliament before final adoption.

Impact: The delay gives businesses additional time to prepare for compliance with high‑risk AI obligations. It also clarifies governance, transparency, and sectoral overlap issues. However, businesses should continue preparing for compliance and avoid delaying implementation while final timelines are confirmed.

Businesses could consider they:

• ensure exempted systems are still registered in the EU high‑risk AI database where required
• reassess eligibility for simplified obligations
• verify that use of sensitive data for bias testing meets the strict necessity standard
• plan earlier transparency measures for AI‑generated content and monitor sector‑specific guidance

EU: Commission updates technology licensing competition rules

On April 16, the European Commission (EC) adopted revised EU competition rules for technology licensing agreements. The update replaces the 2014 Technology Transfer Block Exemption Regulation and related guidance.

Key changes include:

• data licensing: the EC explains how businesses can license data for production. Licensing protected databases is generally seen as competition‑friendly and follows existing technology licensing principles
• joint license negotiations: new guidance explains when businesses can negotiate license terms together. It clarifies the difference between acceptable cooperation and illegal buyer cartels, and outlines practical steps to reduce competition risks
• further changes aim to simplify the application of the rules

The revised rules apply from May 1, 2026.

Impact: Businesses should review licensing agreements in light of the revised rules, ahead of their application.

They should also:

• focus on data licensing and standard related technologies
• reassess competition law risks when using joint negotiation groups
• confirm that technology pools continue to meet safe harbor conditions

EU: EDPB guidance on scientific research and data transfers

On April 16, the European Data Protection Board (EDPB) adopted new GDPR guidelines clarifying when data processing qualifies as scientific research, easing compliance while safeguarding individuals’ rights.

The guidance explains lawful bases, use of broad and dynamic consent, limits on data subject rights, and appropriate safeguards such as anonymization and pseudonymization. The EDPB also approved updated Europrivacy certification criteria, including recognizing Europrivacy as the first European Data Protection Seal that can be used as a transfer safeguard. For international transfers, the EU-US Data Privacy Framework (adopted in July 2023) remains an available adequacy-based mechanism for transatlantic data flows in the research context.

A public consultation on the research guidelines runs until June 25, 2026.

Impact: Businesses involved in R&D or international data transfers hope to gain clearer compliance pathways and a new certification-based option to support cross-border data flows. 

Eversheds Sutherland article

EU: Urban wastewater rules impact on pharmaceutical sector

On March 24, the European Parliament reviewed the Urban Wastewater Treatment Directive’s impact on medicines supply.

Directive (EU) 2024/3019 on urban wastewater treatment entered into force on January 1, 2025 and strengthens wastewater treatment requirements. It introduces extended producer responsibility for pharmaceutical and cosmetic companies.

These businesses must fund at least 80% of micropollutant removal costs by December 31, 2028.

MEPs raised concerns about cost estimates and proportionality of the measures. They highlighted potential impacts on medicine availability, affordability, and supply security.

The debate will inform a resolution vote during the April 2026 plenary session.

Discussions may also consider temporary measures or implementation adjustments.

Impact: The Directive shifts wastewater treatment costs toward pharmaceutical and cosmetic manufacturers.

Businesses may fund pollution removal under the polluter pays principle. This may increase operational costs, especially for generic medicine producers.

Higher costs could affect pricing, supply chains, and product availability. Businesses should assess financial exposure and update compliance and reporting systems. They may need to engage in national producer responsibility schemes.

Member States must establish financing mechanisms by 2028. Implementation will be gradual, with full rollout expected by 2045.

The rules mainly impact pharmaceutical, cosmetics, and wastewater treatment sectors.

EU: Commission announces new digital measures

On March 16, the European Commission announced new measures related to digital regulation, focusing on strengthening data governance, platform accountability, and user protections.

These measures are built on existing frameworks, including the Digital Services Act (DSA) and the Data Governance Act (DGA), and include requirements on data sharing, transparency, and algorithmic oversight, alongside new obligations for large online platforms such as enhanced risk management and content moderation duties. Together, these provisions aim to promote safer digital markets and more responsible platform behavior, while still encouraging innovation and safeguarding personal data and users.

Implementation will require updates to internal governance, systems, and reporting processes. The Commission will monitor compliance and may propose enforcement actions if necessary. The rules complement existing EU frameworks on data protection and platform regulation.

Impact: Businesses operating digital platforms or handling personal data may face increased compliance requirements, including transparency, reporting, and data handling obligations. 

Adjustments to internal governance and systems may be required. Businesses are encouraged to adopt proactive compliance strategies to align with evolving EU expectations.

EU: Legislative progress on Digital Omnibus and AI Act

On March 13, the Council of the EU published its position on the proposed AI Act under the Digital Omnibus package.

Rules for standalone high risk AI systems would apply from December 2, 2027, with embedded systems applying from August 2, 2028. The Council aims to restore the requirement to register AI systems deemed exempt from high risk status. It also aims to reinstate a strict necessity test for processing special categories of data for bias detection. National AI regulatory sandboxes would be delayed to 2 December 2027.

On March 18, the European Parliament (EP) Committees adopted their position as well on the above deadlines.

Impact: The Digital Omnibus package may significantly reshape how businesses operate under EU digital rules. Businesses should assess the AI Act changes and review the updated timelines. Providers and deployers of AI systems may process special categories of personal data to detect and correct bias, with proper safeguards. Expanded AI regulatory sandboxes and real world testing could benefit several key European industries.

Businesses operating in sectors with their own regulators like health and life sciences companies would welcome clarity on any overlapping frameworks cause by AI Regulation.

Eversheds Sutherland article: EU Digital Omnibus: At a glance

EU: EDPB and EDPS Joint Opinion on proposal for EU Biotech Act

On March 10, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) published a Joint Opinion on the European Commission’s proposal for a European Biotech Act. The Act is intended to strengthen the EU biotech and biomanufacturing sectors and to facilitate consistent application of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).

The EDPB and EDPS recommend:

• clarifying the roles of clinical trial sponsors and investigators as sole or joint controllers
• retention periods for personal data, and purposes and safeguards for further processing of personal data for other clinical trials or scientific research
• requiring pseudonymization of personal data whenever it isn’t necessary to process directly identifiable personal data

They also suggest that it would be advisable for the legislators to make it mandatory for the EDPB to produce guidance on how to assess whether clinical trials are GDPR compliant, and for the European Medicines Agency to cooperate with the EDPB in producing guidance that relates to personal data and the use of AI in clinical trials.

Impact: Final adoption of the Act is expected later this year. The recommendations above may not influence the final outcome but businesses in the biotech and biomanufacturing sectors should be prepared for increased compliance burdens and clearer regulatory benchmarks.

EU: Industrial Accelerator Act

On March 4, the European Commission proposed the Industrial Accelerator Act, a central pillar of the EU’s Clean Industrial Deal, aimed at scaling manufacturing capacity, accelerating permitting for strategic projects. A key objective is to increase manufacturing's share of EU GDP to 20% by 2035.

It plans to introduce new “Made in EU” and low carbon preferences in public procurement and investment support.

The proposal includes fast-track permitting for Industrial Manufacturing Acceleration Areas, aiming to shorten the time it takes for manufacturers to build or expand facilities.

Impact: The proposal signals a shift toward mandatory EU origin and low carbon criteria in public procurement and state backed investment, increasing compliance risk for non-EU sourcing and manufacturing models. Although initially focused on energy-intensive industries, “Made in EU” procurement requirements and accelerated permitting of facilities could impact the pharmaceutical sector. Companies may face new permitting regimes and fast track processes, requiring early legal input on site selection, planning, and regulatory sequencing. Foreign direct investment in strategic manufacturing sectors is likely to attract heightened scrutiny and conditionality, including localization, workforce, and technology transfer expectations.

Eversheds Sutherland article

UK

UK: Real-world evidence dialogue program launched

On May 20, the National Institute for Health and Care Excellence (NICE) and Medicines & Healthcare products Regulatory Agency (MHRA) launched a Real-World Evidence (RWE) Scientific Dialogue program. This follows a 2025 pilot demonstrating the value of early regulatory engagement.

The program aims to align expectations on study design, data sources, and methodologies for RWE. It promotes consistency between regulatory and health technology assessment requirements and encourages shared learning outputs. Four workshops will run annually across two application cycles, with optional follow‑up meetings. Applications are open to proposals involving medicines and medical devices using RWE. For the current cycle, expressions of interest close in August 2026.

Selected applicants will be notified in early October, with workshops held in November 2026.

Impact: Interested parties should engage with MHRA and NICE to clarify program expectations and methodologies. RWE is a rapidly expanding area in clinical trials where it could speed up innovative therapies routes to market. Technology businesses may see increased opportunities to support life sciences partners in this area.

UK: Guidance warns on agentic AI adoption risks

On May 15, the UK National Cyber Security Centre published guidance on adopting agentic AI systems.

The guidance explains that these systems can access data, make decisions, use tools, and act towards defined goals. However, their autonomy and complexity introduce heightened risks compared with traditional AI. These include broader access to systems and data, unpredictable behavior, and actions occurring faster than human oversight.

The guidance also notes that issues may be harder to detect and explain due to the wide range of possible actions.

Overall, it emphasizes that agentic AI can deliver benefits but requires careful and controlled adoption.

Impact: Businesses should assess whether agentic AI is necessary or whether lower-risk alternatives could achieve the same outcome. They are encouraged to start with small, controlled pilots and expand use gradually once confidence is established. The guidance emphasizes embedding security from the outset and applying existing cyber security practices. This includes limiting system access, restricting agent actions, and managing supply chain risks.

Businesses should also consider potential failure scenarios and ensure adequate oversight and monitoring, which may increase governance and risk management expectations for AI deployments.

UK: Clinical trials reforms

New UK clinical trial regulations came into force on April 28, introducing the biggest overhaul in over 20 years. The reforms speed up approvals, simplify lower-risk trials and fast-track certain modifications through a new notifiable and ‘Route B’ process.

Regulators can now rely on overseas safety data that meets UK standards and use model-based approaches, while maintaining participant safety. Trial registration and publication of summary results become legal requirements for the first time.

Impact: Businesses in the sector could expect faster trial set-up, reduced regulatory friction and a more attractive UK environment for life sciences investment.

UK: Renewed women's health strategy for England

On April 14, the Government published a renewed Women’s Health Strategy, placing women’s experiences at the center of care. This introduces trials linking patient feedback to provider funding, to drive accountability. Gynecology pathways will be streamlined to reduce waiting lists and speed diagnosis, including endometriosis and fibroids. A single referral point and expanded community services aim to improve access.

New standards aim to address pain relief for invasive gynecological procedures. Research reforms will promote gender‑balanced studies and increased female participation in clinical trials. Funding includes a £1.5 million Femtech Challenge Fund and a £1 million menstrual education program. Women’s voices will inform future policy through a new national partnership. The strategy applies in England.

Impact: Healthcare providers should anticipate greater scrutiny of patient experience, outcomes and pain management standards.

While the Femtech Challenge Fund could be seen as limited it may help to highlight important issues in women's healthcare. It could act as a catalyst for innovation in a growing sector. Opportunities to help close the gender health gap may be seen in a growth in community, digital and diagnostic innovations aligned to women’s health.

UK: Regulators set out approach to agentic AI

On March 31, the Digital Regulation Co-operation Forum (DRCF) published a paper examining agentic AI under existing UK law. The paper explores how current regulatory frameworks can support safe and responsible adoption.

Agentic AI systems act autonomously, using multiple AI agents to complete tasks on a user’s behalf. The DRCF stresses that these systems remain subject to existing legal obligations. These include transparency, fairness, consumer protection, safety, and competition requirements.

The paper highlights potential risks linked to autonomy, such as reduced transparency and challenges for users seeking to contest decisions. It also considers impacts across governance, data protection and cybersecurity, consumer rights, and market competition.

Impact: Business developing agentic AI are encouraged to:

• build transparency and clear oversight into agentic systems from the outset - this includes keeping records, enabling explanations, and allowing meaningful human involvement in important decisions
• assess data protection risks carefully, particularly where systems process personal data autonomously
• monitor risks linked to market behavior, including potential bias or reduced consumer choice

Member regulators will continue working together to address risks and ensure a coordinated regulatory approach.

UK: Regulatory pathway to reduce animal testing

On March 24, Medicines and Healthcare products Regulatory Agency (MHRA) announced measures to accelerate reduced reliance on animal testing in medicines development. It will support greater use of New Approach Methodologies (NAMs), including human‑derived models and computational tools.

It plans to offer early regulatory review of non‑animal data to increase developer confidence. Applications will continue to be assessed case by case, based on total evidence and intended clinical use.

The MHRA plans to introduce a framework by the end of 2026.

The guidance sets principles on when animal testing is unnecessary, limited, or still required. Generic products, biosimilars, and drugs inactive in animals should generally avoid animal testing. Novel pharmacological actions or certain vaccines may still require animal studies.

Impact: Encouraging NAMs participation in clinical trials follows similar regulatory moves in the US and a developing global trend to speed up trial frameworks. By the end of 2026, companies can submit such data for MHRA review before full marketing authorization. There may be opportunities for NAMs to work in partnership with health and life sciences companies to capitalize on the new framework.

UK: Regulatory path for space‑manufactured medicines

On March 5, the Government issued a regulatory pathway for medicines manufactured in space. This multi-agency initiative aims to accelerate safe patient access to space‑enabled pharmaceuticals. Microgravity can improve biologic drug quality, stability and performance for cancer and rare disease treatments.

The new measures include regulatory guidance, case studies, a re‑entry regulatory sandbox and strengthened supply‑chain engagement. The UK Space Agency is leading work with the Medicines and Healthcare products Regulatory Agency (MHRA), the Regulatory Innovation Office and the Civil Aviation Authority.

The Government says existing medicines regulations already support advanced and novel manufacturing approaches, including microgravity production. Demonstration missions and targeted investments are cited as evidence that in‑orbit manufacturing is commercially viable.

Impact: Life sciences businesses are encouraged to engage early with MHRA scientific and regulatory advice services. Interested businesses should take advantage of forthcoming regulatory case studies to fully understand expectations and opportunities.

US

US: Enforcement initiative on product safety labels launched

On May 6, the Consumer Product Safety Commission (CPSC) launched an enforcement initiative focused on fake safety labels and counterfeit certifications. The initiative addresses concerns about unsafe imported products sold through online marketplaces using fraudulent safety markings.

The CPSC issued a Request for Information (RFI) on counterfeit labels, associated safety risks, detection methods and economic impacts. It is also examining links between counterfeit labels, falsified testing and import practices.

RFI comments close on July 6, 2026.

Impact: Although the CPSC focus is on consumer products, safety labels impact pharmaceuticals, disguising illicit drugs as safe regulated products impacts the industry. Businesses importing or selling consumer products could face increased scrutiny of product testing, certification and supply chains. E-commerce platforms and retailers may be expected to strengthen processes to identify and remove non-compliant or falsely labelled products.

US: Real-time clinical trials pilot initiative

On April 28, the Food and Drug Administration (FDA) announced plans to advance real-time clinical trials (RTCT), including two proof‑of‑concept studies and a planned pilot program. The pilot allows endpoints and safety signals to be shared with the FDA in real time.

RTCT aims to reduce delays in data reporting and accelerate regulatory decision‑making. Initial studies have demonstrated technical feasibility for real‑time data sharing. RTCT could reduce pauses between development phases and enable continuous clinical development.

The FDA also issued a Request for Information to shape a broader pilot program, this closed on May 29, 2026. Pilot selection criteria is expected to be completed by August 2026.

Impact: Interested health and life sciences companies should engage with any FDA consultations on pilot design, evaluation metrics, and implementation. In the long term companies should prepare for governance and auditability of near-real-time data streams. They should ensure all data protection procedures are in place.

Health tech businesses involved in AI and automated platforms could see opportunities for greater involvement in RTCT.

US: Certain marijuana products rescheduled

On April 23, the Department of Justice issued a Final Oder rescheduling Food and Drug Administration (FDA) approved marijuana products and state‑licensed medical marijuana products. These products are immediately moved from Schedule I to Schedule III under the Controlled Substances Act.

The action follows a December 2025 executive order aimed at expanding medical marijuana and cannabidiol research. It aims to expand access to approved therapies while maintaining strict federal controls. The change also aims to provide regulatory clarity for researchers, patients, and healthcare providers.

The order does not legalize or decriminalize cannabis under federal law.

For pharmaceutical companies, the text notes that FDA‑approved products containing marijuana are explicitly covered by Schedule III treatment.

The DEA's medical marijuana registration portal went live on April 29, 2026.

Impact: The Final Order does not clarify the position of the medical marijuana industry entirely. Some uncertainty remains over the Drug Enforcement Administration's oversight, interstate commerce mechanics, taxation, and banking access. This uncertainty could lead to further delays or litigation.

The Order could open some avenues for pharmaceutical companies to engage in further medical marijuana and cannabidiol research to develop innovative new products.

US: Accelerated access to psychedelic drug development for mental health

On April 18, the Administration issued an executive order to accelerate treatments for serious mental illness. This prioritizes some psychedelic drugs with Food and Drug Administration (FDA) Breakthrough Therapy designation through National Priority Vouchers.

It aims to reduce regulatory delays in FDA review. The FDA and Drug Enforcement Administration (DEA) are directed to create patient access pathways for investigational psychedelic drugs meeting basic safety requirements. The Department of Health and Human Services is instructed to allocate $50 million through the Advanced Research Projects for Health program to support state psychedelic research.

Included compounds may involve ibogaine under the Right to Try Act. The Attorney General is instructed to begin rescheduling reviews after successful Phase 3 trials and FDA approval.

The policy aims to expand treatment options, particularly for veterans with treatment-resistant mental illness.

Impact: The actions outlined in the executive order see a significant federal policy shift in psychedelic therapies. Manufacturers interested in psychedelic drugs may benefit from expedited FDA review pathways and enhanced federal funding support. They could benefit from earlier patient access under Right to Try.

US: Section 232 tariffs on patented pharmaceuticals

On April 2, the Administration issued a proclamation adjusting imports of patented pharmaceuticals and pharmaceutical ingredients under Section 232 of the Trade Expansion Act. The action follows a Commerce Department investigation finding import dependence threatens national security.

A 100% tariff will apply from July 31, 2026, operating as a floating rate alongside existing most-favored-nation duties. Lower tariff rates apply to companies with approved onshoring plans and most-favored-nation (MFN) pricing agreements. Companies with approved onshoring plans face a 20 percent tariff. Certain partners, including the EU, Japan and the UK, receive reduced rates under trade arrangements. Generic pharmaceuticals and biosimilars are excluded from tariffs at this time. The policy aims to strengthen domestic pharmaceutical manufacturing and supply chain resilience.

On May 13, the Industry and Security Bureau published a Federal Register Notice on the application procedures for pharmaceutical onshoring agreements, granting reduced Section 232 tariffs on eligible imports. Applications are requested by June 12, 2026.

Impact: Pharmaceutical companies could reduce or avoid tariffs by committing to approved onshoring and MFN pricing agreements.

US: Administration outlines federal AI policy blueprint

On March 20, the Administration announced a national framework setting out legislative priorities for AI in the US. The proposals aim to guide Congress toward a single, federal approach to AI governance.

The framework focuses on: protecting children, supporting communities, safeguarding creative works, and defending free expression. It also addresses infrastructure concerns, including energy costs linked to AI data centers and the rise of AI‑enabled fraud.

The framework seeks to promote rapid AI adoption while building public trust and supporting US leadership in AI development.

Impact: The framework signals likely movement toward nationwide AI rules, reducing uncertainty caused by differing state laws. The proposals also point to a more permissive environment for AI testing and deployment.

While the framework is not binding, businesses should treat it as an indicator of future legislative direction. They should begin aligning governance, compliance, and workforce planning accordingly.

US: Guidance advances alternatives to animal testing

On March 18, the Food and Drug Administration (FDA) released draft guidance on validating alternatives to animal testing in drug development. This supports using new approach methodologies (NAMs), based on human‑centric data. It aims to help developers bring safe and effective drugs to market sooner.

Four validation principles are defined: context of use, human biological relevance, technical characterization, and fit‑for‑purpose.

Examples of NAMs include in vitro systems, organoids, organs‑on‑chips, in silico models, and lower‑order organisms.

The guidance does not cover specific methodologies or discovery‑stage applications. The FDA encourages early engagement with review divisions for NAM use.

The FDA took comments on the guidance until May 18, 2026.

Impact: The guidance can be seen as part of a wider US Administration move to speed up drug development and encourage new technological entrants in domestic drug manufacture. Any NAM entrants looking for opportunities to speed up clinical trials should be aware of entering a sector that is still highly regulated. They should take specialist advice to ensure risk strategies are in place.

Further reading

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China’s first blocking response to foreign sanctions: What you need to know

UK: Expansion of corporate liability to all criminal offences committed by senior managers

Global Sustainability & ESG Insights

New EU framework for compulsory licensing of patents in crisis situations

EU adopts its 20th sanctions package against Russia and Belarus

Global AI regulatory update - April 2026

EU: Pharmaceutical Law Reform

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