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    The Organisation for Professionals in Regulatory Affairs
  • Regulatory Rapporteur - July/August 2026
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • AdobeStock_2031070488_main image
      Drug development and regulatory pathways across therapeutic areas
    • AdobeStock_230080191_main image
      Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives
    • AdobeStock_1057710391_main image
      The development of novel influenza drugs: Current regulatory challenges
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      A career in veterinary regulatory affairs: Roles and competencies across the product lifecycle
    • Jana Schalansky
      November 2025 – Contents: Veterinary medicines sessions
    • RR-June-2025-half cover _masthead
      June 2025 – Contents
    • June cover image licensed
      Veterinary medicines: Translating regulation into practice
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      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • 1. image 1 same image in previous MedDev updates
      Medical device standards update: July 2026
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      Medical Device Regulation 2.0: Why stakeholder disagreement is bad for all
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      From gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
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    • AdobeStock_93980790
      EU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment
    • AdobeStock_572256673
      New MHRA framework sets out IMA pathway for rare disease therapies
    • AdobeStock_2070282556
      FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
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      Therapeutics: Navigating diverse regulatory pathways
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      Lifecycle management: Enhancing regulatory agility
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      The regulatory profession: Origins, career development and the road ahead
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      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
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      The Olaratumab experience
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      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
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Pharmaceutical latest

  • AdobeStock_93980790

    EU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment

    2026-07-21T08:05:00+01:00

  • AdobeStock_572256673

    New MHRA framework sets out IMA pathway for rare disease therapies

    2026-07-17T15:17:00+01:00

  • AdobeStock_2070282556

    FAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act

    2026-07-09T15:15:00+01:00

  • AdobeStock_480282897

    European Commission publishes first joint clinical assessment under EU HTA regulation

    2026-07-09T09:45:00+01:00

  • AdobeStock_911354716

    FDA launches Operation TrialBlazer to accelerate US clinical research

    2026-07-09T09:15:00+01:00

  • Environmental impact of pharmaceuticals and regulation in the EU

    Environmental impact of pharmaceuticals and regulation in the EU

    2026-07-03T17:05:00+01:00



  • Half cover_final

    Regulatory Rapporteur July/August 2026 – Contents

    2026-07-02T16:57:00+01:00

  • AdobeStock_2031070488_main image

    Drug development and regulatory pathways across therapeutic areas

    2026-07-01T14:45:00+01:00

  • AdobeStock_230080191_main image

    Navigating the regulatory landscape of adverse events following immunisation: Current challenges and future perspectives

    2026-06-30T15:16:00+01:00

  • AdobeStock_1057710391_main image

    The development of novel influenza drugs: Current regulatory challenges

    2026-06-30T14:55:00+01:00

  • AdobeStock_487121091_main image

    Advancing fertility therapeutics: Scientific, clinical and regulatory challenges in assisted reproduction

    2026-06-30T14:20:00+01:00

  • AdobeStock_1984419336_main image

    Environmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision

    2026-06-30T13:04:00+01:00

  • National Commission

    The National Commission into the Regulation of AI in Healthcare releases survey findings

    2026-06-16T15:12:00+01:00

  • SAFETY- main image

    Enhancing post-market surveillance with Artificial Intelligence and predictive analytics

    2026-06-09T08:30:00+01:00

  • Wegovy IMAGE

    EMA recommends marketing authorisation extension for Wegovy tablets

    2026-06-03T11:56:00+01:00

  • INTEL- main image

    Considerations in building and maintaining regulatory intelligence

    2026-06-02T09:33:00+01:00

  • RIMS- main image

    Driving efficiencies in global submissions through RIMS: Practical perspectives from industry

    2026-06-02T08:36:00+01:00

  • DIVERGENCE- main image

    Navigating divergence: Practical lessons from the UK lifecycle management of licences

    2026-05-29T11:16:00+01:00

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