FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Predict Drug-Induced Liver Injury (DILI)
FDA's ISTAND pilot accepted its first-ever in silico (computational) drug development tool on 3 June 2026 — a model designed to predict drug-induced liver injury (DILI). This is a major regulatory milestone for computational toxicology in drug development.
FDA | Pharmaceuticals | Regulatory AffairsMalaysia NPRA Publishes List of Renewal Approved Veterinary Products
Malaysia's NPRA has published a communication related to the renewal approval of veterinary products, reinforcing regulatory requirements for maintaining product registrations and ensuring continued compliance with veterinary medicinal product regulations.
NPRA | Pharmaceuticals | Regulatory AffairsEMA: New EC Variations Guidelines Now in Full Effect — Updated Classification System Mandatory from 15 January 2026
New European Commission Variations Guidelines, published 22 September 2025, became mandatory for all variation applications submitted to EMA from 15 January 2026. MAHs must now use the revised classification system, PACMP and PLCM tools, and updated eAF version 1.28.0.0.
EMA | Pharmaceuticals | Regulatory AffairsFDA Draft Guidance: Leveraging Prior Knowledge to Accelerate Cell & Gene Therapies (Genome Editing)
The FDA issued draft guidance on 2nd June 2026, to help gene therapy sponsors make greater use of existing scientific and Regulatory knowledge — streamlining submissions for human gene therapy products incorporating genome editing in somatic cells.
FDA | Pharmaceuticals | Regulatory AffairsFDA Extends Acceptance of E2B(R2) Until 30 September 2026
The U.S. Food and Drug Administration has extended acceptance of E2B(R2)-formatted Individual Case Safety Reports (ICSRs) until 30 September 2026, providing additional time for organizations transitioning to E2B(R3). While offering temporary flexibility, the extension does not replace the need for timely E2B(R3) implementation, validation, and compliance readiness.
USFDA | Pharmaceuticals | Pharmacovigilance
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