Training and innovation networks for sustained capacity development related to ethics, regulatory, pharmacovigilance, and related digital regulatory platforms

Overview

Funding for consortia to establish training and innovation networks that strengthen ethics, regulatory, and pharmacovigilance (PV) capacities in sub-Saharan Africa (SSA). Targets institutions aiming to achieve WHO Maturity Level 3 (ML3) benchmarks through digital transformation, workforce development, and regional harmonization.

Who Can Apply

Consortia of at least three independent legal entities from different countries, including:

• One entity from an EU Member State or Horizon Europe-associated country that is also an EDCTP Association member.
• One entity from a sub-Saharan African (SSA) EDCTP Association member country.
• Additional entities from eligible countries (see Geographic Scope).

The EDCTP Association may act as coordinator upon request but does not count toward the three-entity minimum.

Funding Details

• Maximum grant amount: €2,250,000 (lump sum).
• Funding rate: 100% of eligible costs (lump sum basis).
• Financial support to third parties: Up to €60,000 per third party (grants only).

What Is Funded

• Capacity building: Training and twinning networks for ethics committees, regulatory authorities, and PV systems in SSA, including leadership development (e.g., "train-the-trainer" programs).
• Digital transformation: Development of digital platforms for ethics/regulatory reviews, PV data sharing (e.g., AI/big data integration), and emergency preparedness (e.g., joint reviews).
• Harmonization: Alignment with WHO Global Benchmarking Tool and Research Ethics Oversight Benchmarking Tool; streamlining multi-centre trial ethics reviews.
• Emergency preparedness: Accelerated processes for emergency use authorizations (e.g., MEURI).
• Policy and stakeholder engagement: Translation of findings into public health practice, community involvement, and data protection policy development.

Technology / Maturity Requirements

• Target maturity: Proposals must aim to elevate ethics/regulatory/PV systems to WHO Maturity Level 3 (ML3).
• Mentorship: Consortia must include ML3/ML4 agencies to mentor lower-maturity institutions.
• Digital tools: Integration of AI, big data, or digital platforms for ethics/regulatory/PV processes is encouraged.

Key Dates

• Open date: 2026-01-13
• Deadline: 2026-09-01T22:00:00Z

Application Process (High-Level)

• Single-stage submission via the Funding & Tenders Portal.
• Lump sum funding: Proposals must detail budget allocation in a predefined table.
• Technical support: EDCTP Association offers proposal preparation assistance upon request.

Post-Award Obligations

• Reporting: Standard Horizon Europe deliverables and periodic reports.
• Dissemination: Sharing of project results, including potential disclosure to EDCTP Association members and contributing partners.
• Scientific leadership: Mandatory work package for a scientific project leader (if coordinator is not from SSA).
• IP restrictions: EDCTP may object to transfers/exclusive licensing of results for up to 4 years post-project.

Geographic Scope & Language

• Eligible countries:

- EU Member States and Overseas Countries/Territories. - Horizon Europe-associated countries (e.g., UK, Canada, Norway). - EDCTP Association members (e.g., South Africa, Nigeria, Kenya). - Other countries if participation is deemed essential by the granting authority.

• Language: English.

Notes

• Exclusions: Manufacturing capacity building, technology transfer, and local API production are out of scope.
• Diversity priority: Funding decisions may prioritize geographic and thematic diversity (ethics/regulatory/PV).
• Co-funding: Third-party contributions (e.g., foundations) are encouraged to expand budget/impact.
• One Health Approach: Proposals are encouraged to align with this framework where relevant.