Regulatory standards for the quality and safety of substances of human origin—including blood, tissues, cells, and other human-derived materials—intended for human application, covering donation, testing, storage, and distribution.
Foresight tracks Substances of Human Origin (SoHO) developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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Source-backed regulatory and guidance signals tracked by Foresight, with the newest developments first.
EU Council Presidency Issues Second Compromise Text on Amendments to GMO and Organ Transplant Directives
Council negotiators have issued a second presidency compromise text on an EU directive revising the GMO Deliberate Release Directive and the Organs Directive to address placing genetically modified micro-organisms on the market and organ processing. If adopted, this biotech-focused reform will reshape approval and oversight frameworks for GMM-based products and organ processing in the EU, so stakeholders in biotechnology, healthcare and transplant services should track how the final text defines scope, risk controls and compliance timelines.
European UnionEU Council Working Paper WK 2857/2026 Addendum 1 – Spain’s Comments on GMO and Organ Transplant Directive Proposal
In March 2026 the Council circulated a working paper capturing Spain’s comments on the EU proposal to amend the GMO and organ transplant directives under the European Biotechnology Act package. Spain pushes to keep all manipulated human organs, including future xenotransplantation, clearly under health-transplant law rather than product frameworks, signalling tighter governance, data requirements, and ethical safeguards around advanced organ processing are likely as negotiations progress.
European UnionNetherlands Evaluates VWS Policy on Availability of Medicines, Medical Devices and Body Materials
The Netherlands has published an independent evaluation of its policy instruments for ensuring the availability of medicines, medical devices and body materials, concluding that structural shortages stem from global supply dependencies, pricing pressure and fragmented governance, while donation-based supplies remain vulnerable on donor diversity and plasma reliance. The report frames concrete options for VWS and EU partners to rebalance incentives, stock obligations, procurement criteria and data sharing so that affordability policies do not undermine supply security and so that future legislation is grounded in a clearer view of trade-offs and system-wide risks.
NetherlandsEU Parliament ENVI/SANT Committees Consider Biotechnology Act Proposal On GMMs And Organ Processing
In March 2026, the European Parliament’s ENVI and SANT committees held a joint session on a Commission proposal, within the EU Biotechnology Act package, to amend the EU GMO and Human Organs Directives with tailored rules for genetically modified micro-organisms and organ processing before transplantation. If adopted, these changes would simplify authorisation for low-risk GMMs while formalising authorisation and oversight of organ-processing activities, signalling more predictable but potentially tighter controls for biotech developers and transplant providers across the EU.
European UnionEU Council Working Document Proposes Amendments to MDR and IVDR on UDI, Eudamed and International Cooperation
EU Member States in the Council are examining a first cluster of amendments to the Medical Devices Regulation and In Vitro Diagnostic Regulation that would refine scope definitions, expand UDI/Eudamed traceability and transparency, and embed new international cooperation and reliance mechanisms, alongside consequential changes to EMA and AI Act legislation. If adopted broadly in this form, the package would recalibrate registration and data obligations for device and IVD manufacturers—especially around Basic UDI-DI, Eudamed and well-established technology devices—so companies and notified bodies should track how the Council text evolves into a final compromise.
European UnionEU Commission Working Document on Proposal To Amend Directives 2001/18/EC and 2010/53/EU on Genetically Modified Microorganisms and Organ Processing
The European Commission has detailed new streamlined authorization pathways for organ processing and genetically modified microorganisms under the forthcoming Biotech Act. The shift toward a centralized EU registry of authorized technologies will accelerate market access for biotech innovations and reduce administrative barriers for medical operators.
European UnionEU Proposes Major Overhaul of MDR/IVDR to Cut Burdens and Protect Device Availability
The European Commission has proposed a comprehensive revision of the MDR and IVDR frameworks to streamline certification and reduce administrative burdens for medical device manufacturers. This shift toward open-ended certificates and risk-based surveillance offers significant operational relief but introduces new reporting complexities for digital health and cybersecurity compliance.
European Union
United KingdomUS FDA Grants Accelerated Approval To Kresladi Gene Therapy For Severe LAD-I
The US FDA has granted accelerated approval to Kresladi, the first gene therapy for severe Leukocyte Adhesion Deficiency Type I, based on surrogate biomarker endpoints. This decision reinforces the regulatory pathway for advanced therapies in rare diseases while mandating rigorous post-market clinical validation and long-term monitoring.
United StatesRhode Island Bill H8330 Proposes Paid Leave for Blood Donation
Rhode Island has introduced legislation to mandate four hours of annual paid leave for full-time employees to donate blood. If enacted, businesses must integrate this specific statutory entitlement into existing leave policies and payroll compliance systems.
United StatesUS FDA Proposes Split Classification of Blood Irradiator Devices
The US FDA has proposed classifying blood irradiators as Class II or Class III based on clinical use, with a comment deadline of May 18, 2026. Manufacturers of metastasis-prevention devices must prepare for rigorous premarket approval pathways while TA-GVHD system providers face updated performance and labeling controls.
United StatesJapan MHLW Consults On Draft Guideline For Quality Assurance Of Human Cell-Derived Extracellular Vesicle (EV) Medicines
Japan has introduced draft quality assurance guidelines for human cell-derived extracellular vesicle medicines to standardize manufacturing and characterization requirements. This proposal creates a formal regulatory pathway for EV-based therapies, signaling a shift toward harmonized international standards for advanced medicinal products.
JapanEU Parliament ENVI/SANT Committees To Consider Biotechnology Act Proposal On GMMs And Organ Processing
EU Parliament committees will review proposals to modernize biotechnology rules for genetically modified micro-organisms and organ processing in March 2026. The shift toward simplified authorizations and unlimited market consent for GMMs signals a more streamlined regulatory environment for biotech innovation and market access.
European UnionEU's EDPB and EDPS Issue Joint Opinion on European Biotech Act Proposal
EU data protection authorities have issued a joint opinion on the proposed European Biotech Act, demanding stricter GDPR alignment for health and genetic data. Companies should anticipate more rigorous data governance and transparency requirements for clinical trials, AI-driven biomanufacturing, and regulatory sandboxes.
European UnionEU Parliament Public Health Committee Draft Agenda: Votes on EU Pharmaceutical Package and European Biotech Act (18–19 March 2026)
The European Parliament's SANT Committee will vote on the EU Pharmaceutical Package and review the European Biotech Act on March 18–19, 2026. This marks a decisive step toward a comprehensive regulatory overhaul of market authorization, supply chain resilience, and safety standards for the life sciences sector.
European UnionEU Parliament SANT–ITRE Committees Schedule European Biotech Act Presentation For 19 March 2026
EU Parliament committees will review the proposed European Biotech Act in March 2026 to modernize and streamline regulatory frameworks for biotechnology and biomanufacturing. This initiative signals a strategic shift toward accelerated market access and simplified compliance pathways for health, food, and veterinary sectors to boost industrial competitiveness.
European UnionTaiwan TFDA Revises Documentation for Human Cell‑Derived Exosomes in Cosmetics
Taiwan's TFDA has tightened documentation and safety testing requirements for human cell-derived exosomes in cosmetics, effective immediately. Manufacturers must ensure rigorous donor screening and batch-specific pathogen testing, reflecting a more stringent regulatory scrutiny for biotech-derived cosmetic ingredients.
TaiwanEU Council Schedules Working Party Meeting On Proposal To Simplify Medical And In Vitro Diagnostic Device Rules
EU Council has initiated formal discussions on a legislative proposal to simplify the Medical Devices and In Vitro Diagnostic Regulations. This signals a strategic shift toward reducing administrative burdens while modernizing requirements for digital labeling, cybersecurity, and nanomaterial safety to improve market access.
European UnionBrazil Anvisa Starts Optimised Reliance Evaluation For Biological Product Registrations
Brazil has implemented an optimized evaluation queue for biological product registrations, leveraging regulatory reliance on foreign assessments to accelerate market access through 2026. Companies can significantly reduce approval timelines by aligning dossiers with international standards and meeting specific documentation requirements for the reliance procedure.
BrazilEstonia: Medicines Agency Confirms February 2026 Activity Licence Register Changes
Estonia has finalized updates to its pharmaceutical and tissue-handling activity licenses, reflecting changes in manufacturing sites, wholesale authorizations, and key personnel. Impacted organizations must verify that operational shifts and subcontracting arrangements are accurately registered to prevent regulatory disruptions and ensure continuous market access.
EstoniaEU Commission Implementing Decision (EU) 2026/375 on Harmonised Standard EN ISO 20387:2020/A11:2024 for Accreditation Under Regulation (EC) No 765/2008
The European Commission has officially harmonised the EN ISO 20387 standard for biobanking accreditation, effective February 2026. This provides biobanks with a formal presumption of conformity under EU rules, streamlining regulatory compliance and supporting cross-border operations within the EEA.
European UnionThese are just a few of the most recent Substances of Human Origin (SoHO) alerts. Foresight tracks every jurisdiction, every day — and surfaces only what affects your portfolio, with full citations and evidence.
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Definition
Regulatory standards for the quality and safety of substances of human origin—including blood, tissues, cells, and other human-derived materials—intended for human application, covering donation, testing, storage, and distribution.
Industry relevance
Substances of Human Origin (SoHO) developments can change product scope, supplier expectations, market access, reporting duties, and risk ownership. Foresight tracks the signals early so teams can respond before obligations become urgent.
Foresight tracking
Foresight monitors official sources, extracts structured regulatory intelligence, and maps alerts to a customer's products, substances, markets, and priorities so teams see the relevant signal with source evidence for review.
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