ANVISA VigiMed Instruction Manual for Adverse Event Notification in Health Services
The manual provides comprehensive procedural guidance for healthcare services on reporting adverse drug events in the VigiMed system, ensuring adherence to technical and regulatory standards set by ANVISA.
ANVISA | Pharmaceuticals | Regulatory AffairsFDA Final Guidance: Certain Postapproval Requirements and Resources for ANDAs
FDA finalised guidance on 4 June 2026 clarifying the postapproval obligations for Abbreviated New Drug Application (ANDA) holders — covering labelling, chemistry, manufacturing and controls (CMC) changes, and compliance commitments after generic drug approval.
FDA | Pharmaceuticals | Regulatory AffairsFDA 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 Affairs
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