Market Access with AIFA: Your Guide to Italy’s Pharmaceutical Regulatory and HTA Authority

The Italian Medicines Agency (AIFA) is the national authority responsible for drug regulation and health technology assessment in Italy. Established to ensure the safety, efficacy, and quality of medicines, AIFA plays a pivotal role in overseeing the entire lifecycle of pharmaceutical products, from clinical trials to market access and pharmacovigilance. Engaging with AIFA is essential for stakeholders aiming to navigate market access in the Italian pharmaceutical landscape.

aifa.gov.it

Core Functions of AIFA

AIFA’s primary responsibilities include:

•     Authorization of Medicinal Products: Evaluating and granting Marketing Authorizations (MA) for new medicines to ensure they meet rigorous standards of quality, safety, and efficacy.
  aifa.gov.it
•     Pricing and Reimbursement: Negotiating drug prices and determining their reimbursement status within the National Health Service (NHS) to ensure accessibility and sustainability.
•     Pharmacovigilance: Monitoring the safety of medicines post-marketing to promptly identify and manage adverse reactions.
•     Promotion of Research and Development: Encouraging innovation in pharmaceuticals by supporting clinical research and facilitating early access programs for promising therapies.
  aifa.gov.it

Leadership and Key Contacts

As of January 2025, AIFA is led by President Robert Giovanni Nisticò, who oversees the agency’s strategic initiatives and operations.

Contact Details for AIFA

Website: https://www.aifa.gov.it/en/

Postal Address:

Agenzia Italiana del Farmaco (AIFA)
Via del Tritone, 181
00187 Rome, Italy

Telephone: +39 06 5978401

Challenges in Working with AIFA

Engaging with AIFA involves:

•     Understanding Regulatory Procedures: Familiarity with AIFA’s authorization processes and requirements is crucial for successful market access.
•     Timely and Accurate Submissions: Ensuring that all necessary documentation is complete and submitted promptly to facilitate evaluation processes.
•     Stakeholder Collaboration: Working effectively with various healthcare stakeholders in Italy to align with AIFA’s guidelines and standards.

Successful collaboration with AIFA can lead to efficient market entry and favourable HTA and pricing and reimbursement outcomes in Italy.

Opportunities / Solutions with Justin Stindt Consultants

Justin Stindt AIFA expertise ensures:

•     Expert Consultant AIFA Submissions: Creating high-quality submissions for Marketing Authorizations and reimbursement applications.
•     Market Access AIFA Strategies: Developing strategies that align with AIFA’s regulatory framework to optimize market access.
•     Specialist AIFA Processes: Providing insights into AIFA’s procedures to enhance compliance and expedite approvals.

Justin Stindt Consultants specializes in helping clients navigate AIFA’s regulatory and HTA environment to achieve successful market access in Italy.