International quality system for non-clinical health and environmental safety studies, ensuring the reliability and integrity of data used for regulatory assessments of chemicals, pesticides, and pharmaceuticals.
Foresight tracks Good Laboratory Practice (GLP) developments and surfaces the alerts most likely to matter before they turn into missed deadlines, recalls, or escalation work.
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15 April 2026, 19:37
Source-backed regulatory and guidance signals tracked by Foresight, with the newest developments first.
US FDA Issues Guidance on Bioanalytical Method Validation for Biomarkers
On 10 April 2026, the US FDA issued new guidance on bioanalytical method validation for biomarkers, clarifying how sponsors should validate assays used to generate biomarker data in drug-development submissions. Drug developers and CROs relying on biomarker measurements for INDs, NDAs, BLAs, or ANDAs should review this guidance and align method development, validation strategies, and documentation to ensure biomarker data are robust and acceptable for regulatory decision-making.
United StatesNorway Opens Consultation On Amendments To Regulation On Use Of Animals In Experiments
Norway is consulting on stricter animal welfare standards for scientific experiments to align with EU requirements by mid-2026. Life sciences and research organizations must prepare for updated laboratory protocols and infrastructure requirements for aquatic species and rodents.
NorwayUK Home Office Issues 2026 Code of Practice for Care and Accommodation of Animals in Science
The UK Home Office has introduced a new mandatory Code of Practice for the care and accommodation of animals in scientific research, taking effect in June 2026. Organizations must align laboratory infrastructure and husbandry protocols with these updated minimum standards to ensure continued compliance and maintain operational licenses.
United KingdomUK MHRA Sets Out Approach To Medicines Using Non-Animal Methods
The UK MHRA has introduced a formal framework and a 2026 pre-review mechanism to facilitate the use of non-animal testing methods in medicines regulation. This provides a clear pathway for developers to de-risk animal-free evidence packages and signals a long-term regulatory pivot toward scientific justification over traditional animal-based protocols.
United KingdomMichigan CRA Files Formal Complaints Against Infinite Chemical Analysis Labs (Jackson, Michigan)
Michigan's Cannabis Regulatory Agency has initiated formal enforcement against a safety compliance laboratory for failing to adhere to approved testing protocols and quality standards. This action signals intensified oversight of laboratory data integrity and ISO/IEC 17025 compliance, increasing supply chain risk for businesses dependent on third-party testing for market access.
United StatesEuropean Commission States Retracted Glyphosate Review Does Not Affect EU Risk Assessment
The European Commission confirmed in March 2026 that the retraction of a glyphosate safety review paper has no impact on the substance's current EU approval or risk assessment. This decision provides regulatory certainty for glyphosate-based products, signaling that the EU’s assessment framework prioritizes primary regulatory data over secondary academic literature.
European UnionECHA Issues Best-Practice Guidance on Fish Sexual Development Test (OECD TG 234)
ECHA has published standardized technical guidance for Fish Sexual Development Tests to harmonize endocrine disruptor assessments under REACH, BPR, and CLP. Companies must ensure testing protocols align with these best practices to guarantee data acceptance during regulatory evaluations and mitigate the risk of mandatory re-testing.
European UnionSouth Korea MFDS Issues 2026 Basic Plan for Management of Medical Device Non-Clinical Testing Institutions
South Korea has released its 2026 oversight plan for medical device non-clinical testing institutions to align with international reliability standards. Companies must ensure their safety data and laboratory practices meet these updated inspection criteria to maintain regulatory compliance and market access.
South KoreaUS FDA Issues Draft Guidance on Use of New Approach Methodologies in Drug Development
The US FDA has released draft guidance establishing a validation framework for New Approach Methodologies to modernize safety assessments in drug development. This signals a strategic shift toward non-animal testing, requiring sponsors to align validation and reporting protocols with FDA standards to ensure regulatory acceptance of alternative data.
United StatesNew York Assembly Bill A10564 Proposes Restricting Toxicology Testing To State-Authorized Laboratories
New York is moving to restrict toxicology testing certifications exclusively to personnel employed in state-authorized clinical laboratories. Impacted organizations should audit laboratory authorizations and personnel credentials now to prepare for the proposed twelve-month transition period.
United StatesEU/ECHA Article 46 Decision Requires Fish Endocrine Studies for Tonalide (AHTN)
ECHA has mandated registrants of Tonalide to submit fish endocrine studies by May 2029 to clarify environmental safety concerns. Confirmation of endocrine-disrupting properties would likely lead to SVHC identification or EU-wide restrictions, necessitating early supply chain risk assessment for fragrance-dependent products.
European UnionECHA Orders Amphibian Endocrine Disruption Study for Bis(2-Propylheptyl) Phthalate Under REACH
ECHA has mandated an extended amphibian study for high-volume plasticizer DPHP by November 2028 to investigate potential environmental endocrine-disrupting properties. This decision signals a pathway toward potential SVHC identification or further restrictions for a substance widely used in PVC, automotive components, and construction materials.
European UnionCanada Issues Significant New Activity Notice No. 22294 for Stannate Nanomaterial (CAS 12027-96-2)
Canada has introduced Significant New Activity Notice No. 22294 for Stannate, effective March 7, 2026, targeting nanomaterial and aerosolized consumer uses. Companies must submit detailed notifications before expanding into these high-risk applications, signaling stricter oversight of inhalation and nano-scale exposure pathways.
CanadaECHA Science Seminar on INVITES‑IN Tool for Assessing Internal Validity of In Vitro Studies
ECHA has launched INVITES-IN, a standardized tool for assessing the reliability and bias of in vitro studies used in chemical risk assessments. This move strengthens the regulatory framework for non-animal testing data, requiring companies to adopt more rigorous validation protocols to ensure the acceptance of alternative methods in future filings.
European UnionNew Jersey DEP Clarifies FY27 Laboratory Certification Renewal Requirements
New Jersey has finalized the FY27 environmental laboratory certification renewal cycle, requiring electronic submissions by April 1, 2026. Strict enforcement of personnel reporting and updated method parameters means laboratories must audit compliance now to avoid certification downgrades and operational halts.
United StatesSouth Korea MFDS Launches 2026 "Lab Friends" Technical Support Programme For Testing Laboratories
South Korea's Ministry of Food and Drug Safety has launched a technical support and mentoring programme to enhance the competence of private testing laboratories through 2026. Engagement with this programme by contract laboratories will be critical for maintaining the reliability of safety testing and ensuring seamless market access for regulated products.
South KoreaUS HHS/SAMHSA Updates Certified Laboratory List for Federal Workplace Drug Testing
The US HHS has updated the roster of certified laboratories authorized to perform mandatory federal workplace drug testing as of March 2026. Regulated employers and federal agencies must verify their testing providers against this list to ensure compliance with mandatory screening guidelines and avoid legal or operational risks.
United StatesEuropean Pharmacopoeia Commission Clarifies Recombinant Factor C Integration and Future Innovation Pathways
The European Pharmacopoeia has formally integrated Recombinant Factor C as a validated animal-free alternative for endotoxin testing following the mandatory phase-out of traditional rabbit pyrogen tests in early 2026. This transition requires pharmaceutical firms to modernize quality control protocols and risk assessments to align with the new regulatory preference for synthetic reagents and non-animal methodologies.
European UnionEuropean Commission Publishes Factual Summary of GLP Directives Evaluation Consultation
The European Commission has published stakeholder feedback confirming the Good Laboratory Practice framework remains essential for ensuring the integrity of chemical safety data. Future policy direction will likely prioritize reducing administrative burdens while modernizing standards to incorporate digital technologies and non-animal testing methods.
European UnionSETAC Technical Issue Paper — Recommended Minimum Reporting Information for Eco‑Transcriptomics Studies
SETAC has introduced global reporting standards for eco-transcriptomics to standardize data quality in environmental risk assessments. These criteria signal a shift toward the formal integration of New Approach Methodologies into regulatory frameworks, requiring businesses to align their data generation strategies with emerging transparency expectations.
GlobalThese are just a few of the most recent Good Laboratory Practice (GLP) alerts. Foresight tracks every jurisdiction, every day — and surfaces only what affects your portfolio, with full citations and evidence.
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Definition
International quality system for non-clinical health and environmental safety studies, ensuring the reliability and integrity of data used for regulatory assessments of chemicals, pesticides, and pharmaceuticals.
Industry relevance
Good Laboratory Practice (GLP) 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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