This call for tenders aims at speeding up the development of promising Next Generation Therapeutics for Infectious Diseases by adopting a competitive development in phases, under Pre-Commercial Procurement (PCP). The scope of the call is expected to cover the development of innovative therapeutics to treat viral infections, ARDS or sepsis resulting from infections, including pathogen-targeted therapeutics (but not small molecules or monoclonal antibodies) and host-targeted therapeutics, among which but not only direct-acting antivirals, indirect-acting antivirals and novel immune modulators. It may also cover innovative combinations therapies and products designed to be administered through alternative routes to IV. Broad spectrum therapeutics, pathogen-agnostic therapeutics and therapeutics that could reduce or counteract the emergence of viral resistance are of particular interest.
Inception (kick-off) meeting at HaDEA or DG HERA premises in Brussels (or online) within 15 calendar days of contract start Final progress meeting — location: HaDEA or DG HERA premises in Brussels, hybrid, or videoconference Site selection, feasibility evaluation and/or pre-study site visits/screening visits (in-person, location unspecified) On site-trial tasks such as study visit attendance, protocol adherence or study logs (in-person) Monitoring and evaluation of recruiting sites, including preparation for inspections and audits (in-person) Participant recruitment and screening within EU/EU4Health associated countries and outside in duly justified cases (in-person) Conduct of clinical trials including participant recruitment, treatment administration, and follow-up (in-person, Phase 3) Progress meetings (interim coordination meetings) — to be held via videoconference at least every six months Inception meeting — may be held online as an alternative to Brussels premises
Candidates must prove that they have the legal capacity to perform the contract and the regulatory capacity to pursue the professional activity necessary to carry out the work subject to this call for tenders.
Average yearly sum of turnover and other operating income (including e.g. government subsidies or donations excluding variation in stocks) of the last two financial years.
Quick ratio: current assets - stocks - receivables > 1 year / current liabilities above 0.5
Solvency Ratio between total debt and equity: i = Total debt / Equity. Acceptable value: i < 6 and i ≥ 0
The tenderer must prove experience in the research and development of therapeutics for infectious diseases and/or of therapeutics against sepsis or ARDS in agreement with the product developed.
The tenderer must prove laboratory and/or research and development capacities for carrying the necessary quality, clinical and non-clinical activities envisaged for Marketing Authorisation in the EU.
The tenderer must demonstrate the ability to provide a core team with experience in project management and medicinal product development.
Candidates must prove that they have the legal capacity to perform the contract and the regulatory capacity to pursue the professional activity necessary to carry out the work subject to this call for tenders.
Average yearly sum of turnover and other operating income (including e.g. government subsidies or donations excluding variation in stocks) of the last two financial years.
Quick ratio: current assets - stocks - receivables > 1 year / current liabilities above 0.5
Solvency Ratio between total debt and equity: i = Total debt / Equity. Acceptable value: i < 6 and i ≥ 0
The tenderer must prove experience in the research and development of therapeutics for infectious diseases and/or of therapeutics against sepsis or ARDS in agreement with the product developed.
The tenderer must prove laboratory and/or research and development capacities for carrying the necessary quality, clinical and non-clinical activities envisaged for Marketing Authorisation in the EU.
The tenderer must demonstrate the ability to provide a core team with experience in project management and medicinal product development.
Published 2 July 2026 · rebuilt nightly from the official notice.