Agenzia Italiana del Farmaco (AIFA)

Business Profile

Core Value Proposition

Agenzia Italiana del Farmaco provides regulatory oversight, pharmacovigilance, access to medicines, and public information for medicines in Italy.

Target Customer

Italian healthcare providers, hospitals and clinics, patients, pharmaceutical and biotech companies, researchers, and public-sector stakeholders.

Key Differentiator

National medicines regulator with integrated data portals (OsMed Open Data), a national pharmacovigilance network (RNF), and multiple information channels (FarmaciLine, AIFA APP, Firstline) to support safe, affordable, and evidence-based use of medicines.

Implementation Timeline

Guidance and updates are published as they are finalized (e.g., the paracetamol in pregnancy communication published on 23 September 2025).

Pain Points

1Ensuring safe and effective use of medicines and monitoring adverse drug reactions.
2Managing medicine access and affordability through pricing and reimbursement decisions.
3Providing timely, accurate, and accessible information to healthcare professionals and the public.

Key Features

1Pharmacovigilance network (Rete Nazionale di Farmacovigilanza) and ADR reporting.
2Regulatory oversight for drug authorization and market access (pricing and reimbursement).
3Public information channels and scientific communication (FarmaciLine, AIFA APP, Firstline, publications).
4Data portals and analytics (OsMed Open Data) for consumption and expenditure of medicines.
5Clinical trial governance and ethics coordination via ethical committees and coordination centers.

Target Customer Industries

Decision Makers

1Presidente AIFA

Client Results

1Public health guidance and regulatory updates (e.g., paracetamol use in pregnancy) aligned with European authorities; ongoing monitoring of medicine safety.
2Monitoring and reporting of pharmaceutical expenditure (e.g., spesa farmaceutica) to inform policy and budgeting.

Competitive Advantages

1Official national authority for medicines with authority to regulate safety, access, and information.
2Integrated data and analytics through OsMed Open Data and other portals.
3Active pharmacovigilance through the RNF and ADR reporting.
4Multiple channels for information dissemination and engagement with stakeholders (apps and online tools).

Key Benefits

1Safety monitoring and pharmacovigilance

2Regulated access to medicines through authorization and reimbursement

3Public and professional guidance and information

4Data-driven insights on medicine use and spending

Additional Product Information

Product Description

National medicines regulator in Italy that oversees safety, efficacy, pricing and reimbursement, pharmacovigilance, and public information for medicines; provides data portals and communications to stakeholders.

Target Market

Italian healthcare system, pharmaceutical companies, healthcare professionals, researchers, and public sector stakeholders.

Unique Value Proposition

AIFA acts as the centralized national authority delivering regulatory oversight, safety monitoring, market access, and transparent information on medicines, supported by open data portals and multiple communication channels.

Technical Requirements

Web portal access; mobile apps (AIFA APP, FarmaciLine); data portals (OsMed Open Data) available online.

Pricing Model

Pricing and reimbursement decisions are part of government processes; specific pricing details are not provided in the content.

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