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  • Regulatory Rapporteur - September 2026
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  • Regulatory Rapporteur - September 2026
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • EXCIPIENT main image
      Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S
    • MODERN main image
      Modernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment
    • SYNAPSE main image
      Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations
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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
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      June 2025 – Contents
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      Veterinary medicines: Translating regulation into practice
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      China’s volume-based procurement revolution: How policy, procurement and industrial strategy are reshaping medical device market access
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      From regulation to implementation: Medical device serialisation and traceability in India
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      Medical device standards update: July 2026
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      FDA launches final guidance on therapeutic equivalence evaluations
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      FDA consults on the regulation of GenAI-enabled medical devices
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      FDA finalises guidance aimed at widening access to cancer clinical trials
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      Asia-Pacific: A changing regulatory landscape
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      RegRapPod − InConversation with Aman Khera
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      Therapeutics: Navigating diverse regulatory pathways
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      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
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      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
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Pharmaceutical latest

  • AdobeStock_1527594934

    FDA launches final guidance on therapeutic equivalence evaluations

    2026-09-17T14:05:00+01:00

  • Half cover

    Regulatory Rapporteur September 2026 – Contents

    2026-09-04T11:39:00+01:00

  • EXCIPIENT main image

    Regulatory reforms in China: Strengthening excipient quality and accession to PIC/S

    2026-09-03T15:21:00+01:00

  • MODERN main image

    Modernising India’s drug submissions: Embracing eCTD 4.0 for international regulatory alignment

    2026-09-03T11:11:00+01:00

  • SYNAPSE main image

    Navigating gene therapy development in Japan: The SYNAPSE Model for orchestrating interdependent PMDA consultations

    2026-09-02T14:51:00+01:00

  • ATMP main image

    Managing ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific

    2026-09-02T10:58:00+01:00



  • GMO main image

    Navigating the Australian Office of the Gene Technology Regulator: A regulatory affairs perspective on clinical trials involving genetically modified organisms

    2026-09-01T15:47:00+01:00

  • TGA main image

    Pathways to medicine registration in Australia

    2026-09-01T15:05:00+01:00

  • AdobeStock_1761195483

    FDA finalises guidance aimed at widening access to cancer clinical trials

    2026-08-12T11:44:00+01:00

  • AdobeStock_393573411

    CHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough

    2026-08-06T15:03:00+01:00

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    FDA launches new guidance on development of psychedelic drugs to treat medical conditions

    2026-07-31T08:49:00+01:00

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    USP 2025 Annual Drug Shortages Report: Shortages decline but duration increases

    2026-07-21T09:57:00+01:00

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

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

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    New MHRA framework sets out IMA pathway for rare disease therapies

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

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    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

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