• DSCSA — Final Compliance Deadline for Small Dispensers: 27 November 2026

    FDA's Drug Supply Chain Security Act (DSCSA) exemption for small pharmaceutical dispensers expires on 27 November 2026, making full electronic serialization, track-and-trace, and verification-at-receipt compliance mandatory for all U.S. dispensers by that date.

    Consult NowKnow More
    FDA | Pharmaceuticals | Compliance, Audit and Validation

  • EMA IRIS Platform Guide Revision — Mandatory Workflow for Article 61(3) Labeling Submissions

    EMA updated its IRIS Guide for Applicants on 15 June 2026, reinforcing mandatory use of the IRIS platform for all Article 61(3) labeling and PIL update notifications for centrally authorised medicinal products.

    Consult NowKnow More
    EMA | Pharmaceuticals | Regulatory Labeling

  • PRAC Safety-Signal Labeling Updates — June 2026 PRAC Meeting

    EMA PRAC mandates safety-related SmPC and PIL updates following signal assessments adopted during the 8–11 June 2026 PRAC meeting.

    Consult NowKnow More
    EMA | Pharmaceuticals | Regulatory Labeling

  • UAE: Regulatory Incentives and Logistics Strengthen Pharmaceutical Expansion Opportunities

    Positioning the UAE as a Regional Hub for Pharmaceutical Growth & Market Access Published June 13, 2026

    Consult NowKnow More
    EDE | Pharmaceuticals | Regulatory Affairs

  • Saudi Arabia: SFDA Explores Global Best Practices in Advanced Therapies During US Visit

    Strengthening Regulatory Readiness for Cell & Gene Therapies Published June 17, 2026

    Consult NowKnow More
    SFDA | Pharmaceuticals | Regulatory Affairs