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    Quality, safety and efficacy of medicines

    European Medicines Agency, MED - European Medicines Agency

    Quality, safety and efficacy of medicines

    1. Planning notice published

      Sep 20, 6:33 AMSeptember 20, 2024 6:33 AM

    2. Planned competition start

      Jan 14, 12:00 AMJanuary 14, 2025 12:00 AM

    Brief

    Netherlands: Tenders/European Medicines Agency, MED - European Medicines Agency/Quality, safety and efficacy of medicines

    Published deadline passed

    The published deadline has passed. For multi-stage competitions a later tender deadline may still apply — check the notice or portal for the current phase.

    Brief

    Forskning og utviklingsarbeid innen samfunnsvitenskap og humanistiske fag

    The European Medicines Agency (EMA) has framework contracts in place with multiple contractors to perform quality, safety and efficacy studies to generate evidence to support regulatory decision-making for human and veterinary medicines. As these framework contracts will expire in the last quarter of 2025, the Agency is preparing the launch of a new procurement procedure that will be open to economic operators established in the European Union (EU) and the European Economic Area (EEA), with the aim to sign the new framework contracts in the last quarter of 2025. Given the different scientific areas in which EMA requires research, the new procurement procedure will be structured into different lots. While the exact information on the structure and scope of each of the lots will be made available only at the time of launch of the new procurement procedure, the following scientific research areas are envisaged to be covered under the new procurement procedure: (a) translational research aimed at ensuring (non)clinical scientific study results translate into applicable measures that benefit patient health; (b) research to evaluate medicine use in pregnancy and breastfeeding and benefits and risks associated with that use; (c) research to support regulatory decision-making in the area of veterinary medicinal products (VMPs), and associated benefits and risks to public health, animal health, or the environment; (d) methodological and statistical research; (e) qualitative research of the cognitive processes and experiences of patients and healthcare professionals prescribing and using medicines, and applying risk minimisation measures in real life; (f) non-interventional studies measuring the use and effects (safety and effectiveness) of medicines in real-world settings; (g) research in innovative technologies for manufacturing and quality control of medicines; (h) research in computational methods for comparison of molecular structural features in the context of medicines for rare diseases. It is explicitly emphasised that the exact budget and scope of the services may differ from the information in the present Prior Information Notice. Therefore, interested economic operators must carefully assess the technical specifications once the procurement procedure will be published.

    About the bid

      The European Medicines Agency (EMA) has framework contracts in place with multiple contractors to perform quality, safety and efficacy studies to generate evidence to support regulatory decision-making for human and veterinary medicines. As these framework contracts will expire in the last quarter of 2025, the Agency is preparing the launch of a new procurement procedure that will be open to economic operators established in the European Union (EU) and the European Economic Area (EEA), with the aim to sign the new framework contracts in the last quarter of 2025. Given the different scientific areas in which EMA requires research, the new procurement procedure will be structured into different lots. While the exact information on the structure and scope of each of the lots will be made available only at the time of launch of the new procurement procedure, the following scientific research areas are envisaged to be covered under the new procurement procedure: (a) translational research aimed at ensuring (non)clinical scientific study results translate into applicable measures that benefit patient health; (b) research to evaluate medicine use in pregnancy and breastfeeding and benefits and risks associated with that use; (c) research to support regulatory decision-making in the area of veterinary medicinal products (VMPs), and associated benefits and risks to public health, animal health, or the environment; (d) methodological and statistical research; (e) qualitative research of the cognitive processes and experiences of patients and healthcare professionals prescribing and using medicines, and applying risk minimisation measures in real life; (f) non-interventional studies measuring the use and effects (safety and effectiveness) of medicines in real-world settings; (g) research in innovative technologies for manufacturing and quality control of medicines; (h) research in computational methods for comparison of molecular structural features in the context of medicines for rare diseases. It is explicitly emphasised that the exact budget and scope of the services may differ from the information in the present Prior Information Notice. Therefore, interested economic operators must carefully assess the technical specifications once the procurement procedure will be published.

      Contact phone
      +44 20 7418 8400
      Contact email
      procurement@ema.europa.eu
      Address
      Domenico Scarlattilaan 6, NL-1083 Amsterdam

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    See the full notice

    Contracting authority
    European Medicines Agency, MED - European Medicines Agency
    Title
    Quality, safety and efficacy of medicines
    Type
    PlanningFramework agreement
    Main code
    73000000Research and development services and related consultancy services
    Supplemental codes
    73210000Research consultancy services
    Estimated value
    €33,000,000.00
    Duration
    48 months

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