Pharmacovigilance in Italy
How does the drug safety system work in this sunny European country? Follow our guide and get in the picture.
And of course, if you ever need a local consultant, we’re here to help.
Current status of our Italian pharmacovigilance services:
Italy’s RLFV / LCPPV / EU QPPV
AVAILABLE
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Local Literature Screening
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Who is the main drug safety authority in Italy?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The Italian Medicines Agency, known as Agenzia Italiana del Farmaco (AIFA), headquartered in Rome, is responsible for monitoring the safety of medicinal products available on the Italian market.
It collects and analyzes data on adverse drug reactions (ADRs) and maintains related national system known as the Rete Nazionale di Farmacovigilanza.
REGIONAL UNITS UNDER AIFA
AIFA works in collaboration with regional centers and unlike many other country authority websites (which often lack such kind of information), this one shares an easily accessible list of the centers including contact details.
It even goes further in detail as the section with related documents contains spreadsheets directly listing also specific people and their contact information. The last time we checked, the most recent version of the document included 282 person-specific entries!
Useful insights about the authority website
ENGLISH VERSION AVAILABLE, BUT LIMITED
Even though the website provides an English version with most of the content translated, some pages, like the latest news, seem to only be available in Italian.
So, if what you’re looking for something specific, try checking the Italian version and use browser-based auto translation. This way, you might find what’s missing from the English version.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
Do not get immediately turned off by general definitions of pharmacovigilance at the top of the page – if you explore it in more detail, there’s actually a lot of useful content linked.
What we would highlight is definitely the links to a page with legislation references and Q&A documents on PSUR, PASS or DHPC. You might also find it useful to check rules on meeting requests with the authority.
FORMS (AND DOCUMENTS) SECTION
Selected important forms are grouped under linked categories (GMP – Medicinal products, Reporting ADRs), some are also listed at the lower part of this page. Naturally, each of these documents can be downloaded.
The links section at the top of the page also contains references to several very interesting parts of the website, namely: Fees and annual duties, Tenders and contracts and Interaction with AIFA IT Infrastructure.
AIFA MEDICINALI (ITALIAN MEDICINES DATABASE)
National register of medicines for human use. Records include basic information on each approved medicine: name of the pharmaceutical company, form and dosage, package information, active ingredients and ATC code.
DATABASE “TROVA NORME FARMACO”
A standalone database managed by AIFA, where you can find legal provisions and other official documents relating to medicinal products for human use (only in Italian).
A newsletter functionality allows to receive periodic updates about new publications with the possibility to select your topics of interest.
DRUG AUTHORISATION GUIDE
This page gives you a quick overview of everything you need to know and do to get Marketing Authorization in Italy. It links documents you’ll need to check out in order to start the process.
PRESENTATIONS AND SPEECHES
What we really appreciate about AIFA’s website is that it regularly shares slide decks from conferences and events where the agency participates.
It is true that the page and materials are mostly in Italian, but the frequency of updates is really good and published content very insightful, so we suggest you turn on the browser-base translation and have a look.
MOBILE APP & REGULAR PODCAST EPISODES
It is not so common for a national drug authority to have their own mobile app and a podcast, but AIFA does!
While the app seems to be mainly oriented towards general public, AIFA podcast streamed via Spotify offers news and insights on medicines – a useful source of information mainly for healthcare professionals.
Other important institutions & industry groups
MINISTRY OF HEALTH (Ministero della Salute)
The Italian Ministry of Health and the Italian Medicines Agency (AIFA) have a collaborative relationship in overseeing the country’s healthcare and pharmaceutical sectors. The Ministry of Health sets the overall health policies, regulatory framework, and strategic direction.
From our perspective, the most interesting part of the ministry website is the Open Data section with downloadable datasets. It is also useful to know that both Italian Veterinary Medicines Database and Medical Devices Database are hosted there.
Ministry’s website: https://www.salute.gov.it
NATIONAL HEALTH INSTITUTE (ISS)
The Italy’s National Health Institute is a public health research institute established in 1934. It supports the health system through scientific research, surveillance and advisory services.
When visiting the institute’s website, drug safety professionals will most probably head to the publications section. There you can find links to selected Italian scientific journals (Annals of the National Institute of Health, National epidemiological bulletin), but also to ISTISAN Reports, congress materials and a useful Newsletter of the National Institute of Health.
ISS website: https://www.iss.it/
FARMINDUSTRIA
National association of pharmaceutical companies operating in Italy. It represents the interests of drug manufacturers and promotes the development of the pharmaceutical sector (limited English section of the website here).
For Marketing Authorization Holders, especially useful website sections can be the Institutional monitoring and Events.
Not to forget, quite extensive industry publications are available in the Research and data section, especially under the category Reseach in collaboration with Farmindustria (for example The Pharmaceutical CDMO – Survey 2023 or Pharmaceutical Indicators 2024).
Farmindustria website: https://www.farmindustria.it/
EGUALIA (former Assogenerici)
This association represents generic and biosimilar drug manufacturers in Italy. It aims to promote the availability of affordable medicines and supports the development of the generic drug industry.
As such, it collects and shares quite a lot of recent pharma industry news (on both national and EU level), which is the main reason why we list it here.
If you are interested in pharma regulatory environment in Italy, we suggest to include this site between the sources you monitor to stay up to date.
Eugalia website: https://www.egualia.it/it/
SIMEF (La Società Italiana di Medicina Farmaceutica)
SIMeF, the Italian Society of Pharmaceutical Medicine founded in 1964, is another influential organization within the pharma landscape in Italy.
The website of this institution provides access to useful archives of several resources that are worth your attention: the SIMeF Journal (bimonthly newsletter founded in 1964), CIOMS bulletin and IFAPP Today (monthly newsletter by the National Societies of Pharmaceutical Medicine).
SIMeF website: https://www.simef.it/
Some of the most important laws
Essential legislation
Legislative Decree No. 219 of April 24, 2006
This law establishes the general framework for the regulation of medicines in Italy, including pharmacovigilance (article 129).
Ministerial Decree of April 30, 2015
This decree provides detailed guidelines on the organization and operation of the RNF. See related AIFA presentation here.
Law No. 296 of December 27, 2006
The law defines the guidelines and financial support for implementing a program of active pharmacovigilance in Italy.
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
GCP (Good Clinical Practice) Guidelines
GCP Guidelines cover pharmacovigilance practices during clinical development phases.
Essential EU Legislation and EMA Guidlines
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Italy, following terms will be helpful for you to get familiar with:
AIFA (Agenzia Italiana del Farmaco)
→ Main Italian authority on pharmacovigilance
RNF (La Rete Nazionale di Farmacovigilanza)
→ The National Pharmacovigilance Network
RLFV (Responsabile Locale di Farmacovigilanza)
→ local term for LCPPV / Italy QPPV
AIC (Titolare dell’Autorizzazione all’Immissione in Commercio)
→ MAH / Marketing Authorisation Holder
Is LCPPV needed or is EU QPPV enough?
If you need a full translation of the legal instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Italy?
More information can be found on this page, including Adverse reaction (ADR) reporting forms, and more.
Local medical journals to screen
Here are few examples of Italian local literature that medical authorization holders should monitor:
ITALIAN JOURNAL OF MEDICINE (ITJM)
A medical journal covering a broad range of topics.
It’s the official journal of FADOI, the Federation of Associations of Hospital Doctors in Internal Medicine.
Within the Italian healthcare system, it is especially relevant journal and serves as a reliable source of scientific articles for clinicians and healthcare professionals.
ISSN: 1877-9352
MINERVA MEDICA
With a history dating back to 1909, Minerva Medica is a long-established bimonthly journal that publishes medical content (original research, reviews, clinical case studies).
Articles are available in both English and Italian.
The journal uses a hybrid publishing model—subscription-based with optional open-access publishing for authors who wish for broader reach.
ISSN: 1827-1669
RECENTI PROGRESSI IN MEDICINA
A monthly Italian journal founded in 1946 and published by Il Pensiero Scientifico Editore.
As its name suggests, it focuses on recent progress in medicine. It is known for thoughtful updates, practical studies, and occasional cultural perspectives—all in Italian, with some summaries in English or French.
A unique characteristic of the journal is that each issue ends with articles exploring medicine’s ties to culture and the arts.
ISSN: 2038-1840
ANNALI DELL’ISTITUTO SUPERIORE DI SANITÀ
An open access journal by the National Institute of Health (translation of its name is “Annals of the National Institute of Health”). It is a quarterly published source of research articles in biomedicine, translational research and in many other disciplines of the health sciences.
ISSN: 2384-8553
GIORNALE ITALIANO DI CARDIOLOGIA
The official Italian-language journal of the Italian Federation of Cardiology and the Italian Society of Cardiac Surgery. It’s a monthly, peer-reviewed publication.
What we find interesting is that recently, the journal has introduced new sections like ECG of the Month, Cardiac Imaging Highlights, and monthly video summaries. Since early 2025, it has also added a section on artificial intelligence in cardiology.
ISSN: 1972-6481
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
AIFA: Operating Procedure for LCPPVs in Italy
PROCEDURA OPERATIVA AIFA
PER I RESPONSABILI LOCALI DI FARMACOVIGILANZA
Official document defining the operating procedure for RLFV (national role similar to LCPPV in Italy) published by AIFA.
AIFA: The Italian National System of Pharmacovigilance
Management of Pharmacovigilance at AIFA and local level
A slightly old-fashioned slide deck from 2015, but it still provides relevant and extensive overview of how Italian pharmacovigilance system works.
Country REPORTS
How is the health system in Italy organized and funded? What levels of effectiveness, accessibility and resilience does it show? Data to answer questions like these ones is collected and analyzed in the publication.
The Use of Medicines in Italy (2022)
A material by AIFA reporting national pharmaceutical expenditure, prescriptions and related aspects of the Italian healthcare sector.
Scientific publications on pharmacovigilance in italy
Pharmacovigilance and the digital world in Italy: presentation of the results of a national survey
SIMeF and its Pharmacovigilance Working Group “Ernesto Montagna” put together this research paper focused on the observed speed of innovation in pharmacovigilance related to adoption of digital technologies.
Pharmacovigilance and the Italian Medicines Agency
A material focused on general description of the essential aspects of the Italian pharmacovigilance system.
Pharmacovigilance in Italy: An overview
Review of legislative framework related to Italian drug safety system with a specific focus on the challenge of ADRs underreporting.
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