AGENZIA ITALIANA DEL FARMACO

Their core work

AIFA is Italy's national medicines regulatory authority, responsible for approving and monitoring pharmaceuticals on the Italian market. In H2020 projects, they contribute regulatory expertise to initiatives that aim to modernize how medicines are developed, assessed, and made available to patients. Their involvement focuses on bridging regulatory science with health technology assessment (HTA) and reimbursement processes, helping shape frameworks that accelerate patient access to therapies across Europe.

What they specialise in

How they've shifted over time

AIFA's early H2020 involvement (2015-2018) centered on modernizing drug approval processes — adaptive trial designs, multi-party collaboration between regulators, HTA bodies, and industry. Their later projects (2019-2022) shifted toward building regulatory science capacity, training academics, and institutionalizing regulatory knowledge. This suggests a move from exploring new regulatory models to embedding and scaling those models through education and workforce development.

AIFA is moving from participating in regulatory innovation pilots toward building sustainable regulatory science infrastructure and training capacity, making them a strong partner for projects that need regulatory authority involvement in capacity-building or policy harmonization.

How they like to work

AIFA participates exclusively as a consortium partner, never as coordinator — consistent with their role as a regulatory authority contributing domain expertise rather than managing research projects. They work in large consortia (69 unique partners across just 3 projects), which reflects the multi-party nature of regulatory reform initiatives involving industry, academia, patient organizations, and other regulators. Their modest funding shares (EUR 28k-57k per project) indicate they serve as expert advisors rather than primary research executors.

Despite only three projects, AIFA has connected with 69 unique partners across 22 countries, reflecting the broad, multi-national consortia typical of IMI and regulatory harmonization initiatives. Their network spans virtually all of EU and associated countries.

What sets them apart

AIFA is a national medicines regulatory authority — one of the few organizations that can bring actual regulatory decision-making power and real-world approval experience to a consortium. Unlike academic groups studying regulation theoretically, AIFA implements these frameworks daily. For any project needing credible regulatory authority input, endorsement, or a pathway to policy impact in Italy's pharmaceutical market, AIFA is an essential partner.

Highlights from their portfolio

• ADAPT-SMART
  Addressed the full lifecycle from adaptive clinical trials through HTA to reimbursement — a rare end-to-end regulatory reform initiative involving multiple regulatory bodies.
• STARS
  Focused on strengthening regulatory science training in academia, positioning AIFA as a bridge between regulatory practice and university education.
• PARADIGM
  Tackled systematic patient involvement in medicines development, an increasingly important regulatory requirement across Europe.