Substances of Human Origin (SoHO)

EU 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 proposed authorization pathways for organ processing and genetically modified microorganisms under the forthcoming Biotech Act. The shift toward a centralized EU list of authorized technologies signals a move to streamline market access and reduce administrative barriers for medical and biotech operators.

1 Apr 2026, 14:32data.consilium.europa.euEuropean Union

EU Proposes Major Overhaul of MDR/IVDR to Cut Burdens and Protect Device Availability

The European Commission has proposed a major overhaul of the MDR and IVDR frameworks to simplify compliance and prevent supply shortages, with adoption expected by mid-2027. This shift toward open-ended certification and risk-based surveillance offers significant operational relief for manufacturers but requires careful navigation of emerging digital and cybersecurity reporting obligations.

29 Mar 2026, 17:30eur-lex.europa.euEuropean UnionUnited Kingdom

US 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 (LAD-I). This decision confirms the viability of biomarker-based approval pathways for gene therapies, provided manufacturers commit to rigorous post-market clinical validation.

28 Mar 2026, 20:29fda.govUnited States

Rhode Island Bill H8330 Proposes Paid Leave for Blood Donation

Rhode Island has introduced legislation (H8330) that would mandate four hours of annual paid leave for full-time employees to donate blood. If enacted, employers will need to update leave policies and payroll systems to accommodate this specific statutory entitlement within their broader compliance frameworks.

25 Mar 2026, 21:31webserver.rilegislature.govUnited States

US FDA Proposes Split Classification of Blood Irradiator Devices

The US FDA proposes classifying blood irradiators as Class II or Class III based on clinical use, with a comment deadline of May 18, 2026. Manufacturers must prepare for rigorous premarket approval (PMA) pathways for metastasis-prevention devices and updated performance and labeling controls for TA-GVHD systems.

19 Mar 2026, 19:36federalregister.govUnited States

Japan MHLW Consults On Draft Guideline For Quality Assurance Of Human Cell-Derived Extracellular Vesicle (EV) Medicines

Japan's MHLW has proposed a new quality assurance guideline for human cell-derived natural extracellular vesicle (EV) medicines, with consultation open until April 16, 2026. This framework establishes critical manufacturing and characterization standards for EV-based therapies, signaling a formal path for market authorization and alignment with international quality expectations.

19 Mar 2026, 19:29public-comment.e-gov.go.jpJapan

EU 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 (GMMs) and human organ processing on March 24, 2026. The shift toward simplified authorizations and unlimited market consent for GMMs signals a more streamlined regulatory environment for biotech innovation and market access.

19 Mar 2026, 12:42europarl.europa.euEuropean Union

EU'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, calling for stricter GDPR alignment and clearer rules for processing health and genetic data. Companies should prepare for more rigorous data governance requirements in clinical trials and AI applications as these recommendations shape the final legislative negotiations.

14 Mar 2026, 14:13data.consilium.europa.euEuropean Union

EU 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 is scheduled to vote on the EU Pharmaceutical Package and review the European Biotech Act on March 18–19, 2026. This marks a critical step toward finalizing a comprehensive regulatory overhaul that will reshape market authorization, supply chain resilience, and safety standards for the life sciences sector.

13 Mar 2026, 10:50europarl.europa.euEuropean Union

EU Parliament SANT–ITRE Committees Schedule European Biotech Act Presentation For 19 March 2026

EU Parliament committees will review the proposed European Biotech Act on March 19, 2026, marking a key step in streamlining biotech and biomanufacturing regulations. This initiative signals a shift toward faster market access and simplified regulatory pathways for health, food, and veterinary biotech sectors to boost EU industrial competitiveness.

13 Mar 2026, 08:37europarl.europa.euEuropean Union

Taiwan TFDA Revises Documentation for Human Cell‑Derived Exosomes in Cosmetics

Taiwan's TFDA has updated the mandatory documentation and safety testing requirements for human cell-derived exosomes in cosmetics, effective immediately. Manufacturers must now provide more rigorous donor screening, pathogen testing, and batch-specific safety data, signaling a stricter regulatory pathway for biotech-derived cosmetic ingredients.

13 Mar 2026, 06:27fda.gov.twTaiwan

EU Council Schedules Working Party Meeting On Proposal To Simplify Medical And In Vitro Diagnostic Device Rules

The EU Council has commenced formal discussions on a legislative proposal to simplify the Medical Devices (MDR) and In Vitro Diagnostic (IVDR) frameworks. This initiative signals a strategic shift toward reducing administrative burdens and modernizing requirements for digital labeling, cybersecurity, and nanomaterials to improve market access.

9 Mar 2026, 17:26data.consilium.europa.euEuropean Union

Brazil Anvisa Starts Optimised Reliance Evaluation For Biological Product Registrations

Brazil’s Anvisa has activated an optimized evaluation queue for biological product registrations, leveraging regulatory reliance on foreign assessments to accelerate approvals through December 2026. Manufacturers can achieve faster market entry by aligning dossiers with international standards and specific reliance criteria, significantly reducing wait times for high-priority biological and pharmaceutical products.

9 Mar 2026, 14:41gov.brBrazil

Estonia: Medicines Agency Confirms February 2026 Activity Licence Register Changes

Estonia’s Medicines Agency has finalized February 2026 updates to the activity-licence register, covering pharmaceutical manufacturing, wholesale, and tissue handling permissions. Operators must verify that site relocations, personnel changes, and subcontracting arrangements are accurately reflected in the official register to ensure uninterrupted compliance and supply chain integrity.

9 Mar 2026, 14:41ravimiamet.eeEstonia

EU Commission Implementing Decision (EU) 2026/375 on Harmonised Standard EN ISO 20387:2020/A11:2024 for Accreditation Under Regulation (EC) No 765/2008

The EU has officially harmonised the EN ISO 20387 standard for biobanking accreditation, effective February 2026. Biobanks can now leverage this standard to secure a presumption of conformity with EU accreditation requirements, reducing compliance friction and supporting EEA-wide market access.

26 Feb 2026, 12:50eur-lex.europa.euEuropean Union

Japan MEXT Publishes Consultation Results and Adopts Amendments to Human ES/iPS Cell Research Guidelines

Japan has finalized amendments to four bioethics guidelines governing human ES and iPS cell research, effective February 2026. Research institutions must ensure internal ethics protocols and reporting procedures align with updated oversight requirements for stem cell establishment, distribution, and use.

15 Feb 2026, 19:19public-comment.e-gov.go.jpJapan

Japan MHLW Consults On Amendments To Guidance And Q&A On Standards For Biological Raw Materials

Japan’s MHLW is consulting on updated operational guidance for biological raw materials used in pharmaceuticals and medical devices (February 2026). Manufacturers must prepare for revised donor screening, viral inactivation, and traceability requirements to ensure continued market access for bio-derived products.

13 Feb 2026, 07:58public-comment.e-gov.go.jpJapan

Japan Amends Standards for Biological Preparations

Japan published amendments to the Standards for Biological Preparations on February 10, 2026, updating technical specifications for biological medicinal products. Manufacturers must review revised monographs and test methods to ensure continued compliance with Japanese quality and safety standards.

12 Feb 2026, 15:38kanpo.go.jpJapan

EU Council Schedules Working Party Meeting on European Biotech Act and GMM Directive Proposal

The EU Council is advancing negotiations on the European Biotech Act and updated rules for genetically modified micro-organisms (GMMs) in early 2026. This signals a shift toward a more integrated regulatory framework for biomanufacturing, requiring firms to align long-term R&D and market entry strategies with new EU-wide standards.

9 Feb 2026, 19:07data.consilium.europa.euEuropean Union

South Korea MFDS Consults On Draft Amendment To Standards And Test Methods For Biological Products (Public Notice 2026-57)

South Korea's MFDS is proposing to extend the shelf-life of raw plasma to three years and introduce new quality standards for specific blood preparations. These updates aim to enhance supply chain flexibility for plasma-derived therapies while ensuring rigorous safety and testing protocols for emerging biological products.

3 Feb 2026, 13:51mfds.go.krSouth Korea