• EMA: 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.

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    EMA | Pharmaceuticals | Regulatory Affairs

  • FDA Draft Guidance: Leveraging Prior Knowledge to Accelerate Cell & Gene Therapies (Genome Editing)

    The FDA issued draft guidance on 2nd June 2026, to help gene therapy sponsors make greater use of existing scientific and Regulatory knowledge — streamlining submissions for human gene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.

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    FDA | Pharmaceuticals | Regulatory Affairs

  • FDA 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.

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    USFDA | Pharmaceuticals | Pharmacovigilance

  • Jordan Draft Framework for Pharmaceutical Product Licensing and Regulatory Compliance

    Jordan has issued draft instructions for the licensing, registration, import, distribution, and post-market oversight of pharmaceutical and cosmetic products. The framework also strengthens requirements for GMP, traceability, labeling, inspections, and market authorization compliance.

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    JFDA | Pharmaceuticals | Regulatory Affairs

  • Statistical Approaches to Establishing Bioequivalence

    FDA guidance providing recommendations to sponsors/applicants using equivalence criteria in analyzing in vivo or in vitro bioequivalence studies for INDs, NDAs, ANDAs, and supplements. Discusses average, population, and individual BE approaches to compare bioavailability measures

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    USFDA | Pharmaceuticals | Regulatory Affairs