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Clinical trials and investigations

Guidance and regulation

27 results

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  • Clinical evaluation for vaccines

    The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)

    • From: UK Health Security Agency
    • Updated:
  • Procedures for UK Paediatric Investigation Plan (PIPs)

    The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Access to Electronic Health Records by Sponsor representatives in clinical trials

    The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • Antimicrobial resistance (AMR)

    VDEC responds strategically to AMR pathogens and new emerging threats (fungi, viruses, and bacteria), by determining the most appropriate research goals to combat these pathogens

    • From: UK Health Security Agency
    • Updated:
  • How VDEC develops and evaluates vaccines

    From discovery to real-world impact, VDEC equips scientists with the expertise and facilities to navigate each step in the development of vaccines and therapeutics.

    • From: UK Health Security Agency
    • Updated:
  • Clinical trials applications for Coronavirus (COVID-19)

    The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated:
  • MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

    Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

    • From: Medicines and Healthcare products Regulatory Agency
    • Updated: