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    Quality, safety and efficacy studies of medicines

    European Medicines Agency, MED - European Medicines Agency

    Quality, safety and efficacy studies of medicines

    1. Competition notice published

      Feb 5, 12:23 PMFebruary 5, 2025 12:23 PM

    2. Questions deadline

      Apr 13, 10:00 PMApril 13, 2025 10:00 PM

    3. Tender submission deadline

      Apr 30, 10:00 AMApril 30, 2025 10:00 AM

    4. Opening date

      May 2, 9:00 AMMay 2, 2025 9:00 AM

    5. Tender validity period

      Jan 30, 11:00 AMJanuary 30, 2026 11:00 AM

    Brief

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

    Expired

    The competition has expired without a winner being announced.

    Brief

    Forskning og utviklingsarbeid innen samfunnsvitenskap og humanistiske fag

    European Medicines Agency (EMA) trenger tjenester fra forskningsorganisasjoner for å utføre pre- og post-godkjenningsstudier på kvalitet, sikkerhet og effekt av humane og veterinære legemidler, med en rammeavtale over 4 år og en maksimal totalverdi på 160 millioner euro. Forskningsomfanget dekker både nasjonalt og sentralt godkjente medisinske produkter, samt ikke-produktrelaterte emner, fordelt på 7 ulike kategorier: translasjonsforskning, veterinærforskning, metodologisk/statistisk forskning, kvalitativ forskning, farmakoepidemiologisk forskning, innovative teknologier, og beregningsmetoder for sammenligning av molekylære strukturelle egenskaper i konteksten av medisiner for sjeldne sykdommer. ECDC deltar også som oppdragsgiver kun for Lot 5 farmakoepidemiologisk forskning. Tildelingskriteriene er basert på kvalitet (70%) og pris (30%).

    About the bid

      EMA seeks to procure the services of research organisations to perform pre- and post-authorisation studies on the quality, safety and efficacy of human and veterinary medicines, generating complementary evidence to support regulatory decision-making. The scope of research covers both nationally and centrally authorised medicinal products, as well as non-product related topics. Studies may concern research under 7 Lots: Lot 1 translational research; Lot 2 veterinary research; Lot 3 methodological/statistical research; Lot 4 qualitative research; Lot 5 pharmacoepidemiological research; Lot 6 innovative technologies; Lot 7 computational methods for comparison of molecular structural features in the context of medicines for rare diseases. ECDC is also participating as a contracting authority only with respect to Lot 5 pharmacoepidemiological research.

      Contact phone
      +44 20 7418 8400
      Contact email
      EMA-2024-OP-0016@ema.europa.eu
      Address
      Domenico Scarlattilaan 6, NL-1083 Amsterdam

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    Award Criteria

    • Description

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    • Description

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    See the full notice

    Contracting authority
    European Medicines Agency, MED - European Medicines Agency
    Title
    Quality, safety and efficacy studies of medicines
    Type
    CompetitionFramework agreementPrequalification
    Main code
    73110000Research services
    Supplemental codes
    73000000Research and development services and related consultancy services73210000Research consultancy services
    Estimated value
    €16,000,000.00
    Duration
    48 months

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