AIFA (Agenzia Italiana del Farmaco)

Who regulates medicines in Italy?

In one sentence

AIFA is Italy's medicines regulator: a public body under the Ministry of Health that authorises, prices and watches over medicines for human use.

It runs the national pharmacovigilance system: every suspected reaction reported in Italy lands in one database, the Rete Nazionale di Farmacovigilanza (RNF), and the agency passes it to the European Union (EU).

Where it sits

MinistryMinistero della Salute, which directs it
Public bodyAgenzia Italiana del Farmaco
PartnersThe regions, their pharmacovigilance centres, and a responsible person in every hospital and company
DatabaseRete Nazionale di Farmacovigilanza (RNF)Suspected reactions land here

Think of it like this

Think of a country where every hospital has a named fire warden. Whoever smells smoke tells the warden within two days, the warden logs it in one national register within a week, and head office passes the serious alarms to Europe within fifteen.

Key insights

Born on New Year’s DayA named person everywhereTwo days, not wheneverCompanies fund the watch

A 2003 decree-law created the agency with effect from 1 January 2004, out of the Ministry of Health’s medicines directorate. Authorisation, price and safety sit under one roof. Chapter 1 tells the story.

Every hospital, local health unit and company names a responsible person for pharmacovigilance, registered in the national network. The regions approve the users; only they can enter a report.

An Italian doctor or pharmacist does not report when convenient: the 2015 decree says within two days, and within 36 hours if the medicine is biological. Chapter 2 sets the clocks.

Companies pay 5 percent of their yearly promotional spend into an agency fund for active pharmacovigilance and independent information. The regions drew 58.5 million euro of pharmacovigilance funds for 2018 to 2022.

Jump to: 1 Three moments 2 Your report, their clock 3 What Italy adds to the EU rules 4 Test yourself

Chapter 1

Which three moments made AIFA what it is?

Pick a year. Each changed who decides, who reports, and how fast.

2004One agency for medicines2015Europe’s rules, Italy’s clocks2024One committee, not two

One agency for medicines

Article 48 of decreto-legge 269 of 2003 established the Agenzia Italiana del Farmaco with effect from 1 January 2004: a body with its own legal personality, directed by the Ministry of Health. The ministry’s medicines directorate moved across; the old medicines commission ceased.

The same article gave it the price talks: from that day every reimbursed medicine’s price is negotiated between the agency and the producer.

What it left behind: one body for authorisation, price and safety, and a fund for active pharmacovigilance paid by companies.

Europe’s rules, Italy’s clocks

The EU’s 2012 pharmacovigilance package needed an Italian procedure. The 2013 budget law asked the Minister of Health for one decree, and the decree of 30 April 2015 delivered it, implementing Directives 2010/84/EU and 2012/26/EU. The day it took effect, the pharmacovigilance chapter of the 2006 medicines code was repealed.

It fixed the Italian clocks that still run: two days for a professional to report, 36 hours for a biological medicine, seven days for the facility’s responsible person to validate the case in the national network, and 15 or 90 days for the agency to pass it to EudraVigilance. Patients may report directly on the agency’s web portal.

What it left behind: the one decree that sets every Italian pharmacovigilance deadline.

One committee, not two

A 2022 decree-law rewrote the agency’s organs, with effect from the appointment of its first President. Today they are the President, a Board of Directors of the President and four members, and a Board of Auditors.

The ministerial decree of 8 January 2024 then amended the 2004 regulation and created the Commissione Scientifica ed Economica (CSE): one committee of ten that took over the work of the former Scientific-Technical Committee and Price and Reimbursement Committee. The agency’s technical-scientific director and the president of the national health institute sit on it by right; the others serve three years.

What it left behind: one table where the science of a medicine and its price are weighed together.

Chapter 2

Your report, their clock

A case has reached your company. The 2015 decree sets the deadline for a suspected adverse drug reaction (ADR) with two questions: is it serious, and was it in the EU? Pick a cell.

In the EUOutside the EUSeriousSerious, in the EUSerious, outside the EUNot seriousNot serious, in the EUNot serious, outside the EU

Or you are not a company at all: a doctor or pharmacist in Italy or a patient in Italy

Every serious suspected reaction, in the EU or a third country, within 15 calendar days of the day you learned of it. One Italian twist: a case already in the national network is the agency’s to send, not yours. Decreto 30 aprile 2015, article 23

A non-serious suspected reaction in the EU within 90 calendar days of the day you learned of it, again unless it already sits in the national network. Decreto 30 aprile 2015, article 23

A non-serious reaction outside the EU is not on the article 23 list. It stays recorded in your pharmacovigilance system, accessible at one point in the EU. Decreto 30 aprile 2015, articles 17 and 23

Promptly, and in any case within two days, on the agency’s form: to the responsible person of your facility, or straight into the national network through the agency’s portal. For a biological medicine the limit is 36 hours. Decreto 30 aprile 2015, article 22

No deadline for you. Report to a professional or directly to the national network on the agency’s website. The facility’s responsible person validates the case within seven days; the agency then passes a serious case to EudraVigilance within 15 days, a non-serious one within 90. Decreto 30 aprile 2015, articles 22 and 24

I medici e gli altri operatori sanitari sono tenuti a segnalare tempestivamente, e comunque entro due giorni, le sospette reazioni avverse da medicinali di cui vengono a conoscenza nell’ambito della propria attività.
Decreto 30 aprile 2015, article 22: professionals must report promptly, and in any case within two days

Every case ends up in the Rete Nazionale di Farmacovigilanza, which links health facilities, the regions and companies. Only registered users enter it, each enabled by their region or company; the reports go on to EudraVigilance and are public on ADRreports.

Chapter 3

What does Italy add to the EU rules?

The EU directive sets the floor and the European Medicines Agency (EMA) runs the shared database. Five places where Italy built its own layer on top.

	The EU rule	Italy’s own layer
Reports from professionals	Member States encourage patients and professionals to report	Professionals must report within two days, 36 hours for a biological; every hospital names a responsible person who validates each case within seven days
The company’s cases	Every serious case goes to EudraVigilance within 15 days	Cases already in the national network are the agency’s to send; the company follows them up through the facility’s responsible person
The company’s people	A qualified person for pharmacovigilance, resident in the EU	On request, a national contact person who reports to that qualified person and registers in the network
Who pays	Pharmacovigilance funds stay under the authority’s control, to keep it independent	Companies pay 5 percent of their promotional spend into an agency fund; the regions draw their share by agreement, 58.5 million euro for 2018 to 2022
Who sets the price	Prices stay national; the EU only sets deadlines and transparency	The agency negotiates the price of every reimbursed medicine with the producer, advised by its Scientific and Economic Committee

Show the legal references

Reports: Directive 2001/83/EC, Article 102(a); Decreto 30 aprile 2015, article 22.
Cases: Regulation (EC) No 726/2004, Article 24(1); Decreto 30 aprile 2015, article 23(4) and (7).
People: Directive 2001/83/EC, Article 104(3)(a); Decreto 30 aprile 2015, article 17(5) and (6).
Funds: Directive 2001/83/EC, Article 105; Decreto-legge 269/2003, article 48(18) and (19); Decreto 30 aprile 2015, article 19.
Price: Council Directive 89/105/EEC; Decreto-legge 269/2003, article 48(33).

Same Europe, tighter clocks: a professional has two days, every hospital a named person, and the agency sends the company’s Italian cases.

The facts, in one place

What it is	A public body with legal personality and autonomy, directed by the Ministry of Health and supervised by it and by the Ministry of Economy and Finance.
Since	1 January 2004, under article 48 of decreto-legge 269 of 30 September 2003, converted by law 326 of 2003.
Who decides	A President and a Board of Directors of five, appointed by the Minister of Health; two general directorates, 6 divisions, 43 offices; a Scientific and Economic Committee of ten advises on science and price.
Seat	Via del Tritone 181, Rome.
Safety system	The Rete Nazionale di Farmacovigilanza, with a responsible person in every facility and company, and regional centres; Italian reports are public on ADRreports; signals are assessed through the Pharmacovigilance Risk Assessment Committee (PRAC).
Inspects	Manufacturing sites, distributors, clinical trials and the pharmacovigilance systems of marketing authorisation holders; mutual recognition with Canada and the United States.
Member of	The Pharmaceutical Inspection Co-operation Scheme (PIC/S) since February 2000; the International Coalition of Medicines Regulatory Authorities (ICMRA); the Heads of Medicines Agencies (HMA); the work of the World Health Organization (WHO) and the International Council for Harmonisation (ICH).

Don’t confuse it with: the Ministry of Health

AIFA

The regulator

Grants: marketing authorisations and negotiates the price of every reimbursed medicine
Runs: the national network and forwards each case to EudraVigilance
Example: approves the educational material a company hands out before launch

Ministero della Salute

The ministry above it

Directs: the agency, appoints its organs and writes its regulation
Issues: the pharmacovigilance decree, such as that of 30 April 2015
Example: regulates veterinary medicines through its own directorate, a PIC/S member since 2020

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“A company must send every Italian case it hears about to EudraVigilance itself.”

MythTruth

MythYou got it.Not quite.

The 2015 decree excludes cases already in the national network from the company’s submissions: the agency sends those within 15 or 90 days.

“A doctor in Italy has two days to report a suspected reaction, and 36 hours if the medicine is biological.”