Insights

The Italian Medicines Agency (AIFA) has introduced a new framework to streamline price and reimbursement (P&R) negotiations, aiming to shorten timelines, accelerate patient access, and focus regulatory effort on high‑complexity dossiers.

The reform introduces two pathways: simplified procedures and fast‑track procedures.

Simplified procedures bypass the Scientific and Economic Commission (CSE) and are directly reviewed by AIFA’s Pricing and Reimbursement Office and the Board of Directors. They apply to well‑established scenarios such as equivalents and biosimilars, extension of indications, packaging changes, parallel imports, and automatic renegotiations via a Smart Dossier, provided pricing aligns with predefined benchmarks.

Fast‑track procedures still involve the CSE but rely on standardized assessments and predefined negotiation parameters. They cover cases such as strength or dosage changes, fixed‑dose combinations, renegotiations for drugs in short supply or under spending caps, and streamlined classification in Class C when comparable products (e.g. vaccines) are already classified within the same reimbursement framework.

Overall, AIFA is moving toward a more agile, risk‑proportionate P&R system—reducing administrative burden, improving predictability for companies, and enabling faster access to medicines for patients.

In this evolving regulatory landscape, targeted local expertise becomes essential. Regulatory Pharma Net (RPN) supports pharma and biotech companies in assessing eligibility for simplified or fast‑track pathways, preparing aligned dossiers, and managing interactions with AIFA. This approach helps companies navigate procedural changes efficiently and make effective use of the new opportunities offered by the updated framework.