Pharmacovigilance in Argentina
How is it with drug safety system in “the Land of Silver”? Follow our guide and you will be in the picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Argentine pharmacovigilance services:
Argentina’s Contact Person
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Argentina?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Argentina is the ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), headquartered in Buenos Aires. ANMAT is responsible for regulating and overseeing the safety of medications and medical devices in the country.
In this country we can find decentralized pharmacovigilance system, regional centers are part of the Sistema Nacional de Farmacovigilancia, SNF.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website has English version, however it is little bit simplified, there’s limited content in English, but the most important things should be translated.
Therefore, if you cannot find what you’re looking for, we suggest you to use the website originally in Spanish and use translator, this way you have potentially much bigger chance to find what you’re looking for.
MIX OF TWO INTERFACES
It seems like parts of the ANMAT website are modernized and use a new look, but some of the content is still linked and accessible only through the previous version of the website which uses different colors and navigation elements.
This results into a situation where some old navigational elements point towards non-existent pages, but it will probably change in time.
Interesting website sections related to pharmacovigilance
NATIONAL PHARMACOVIGILANCE SYSTEM
A high-level section providing links to the most important subpages containing information about PV system in Argentina, sadly it’s only in Spanish.
GENERAL / PHARMACOVIGILANCE REGULATIONS
A collection of Argentine medical-related regulations in one place. It might be useful for you to filter the table to pharmacovigilance category only, as there are hundreds of entries in the default view, only in Spanish. The page also exists in a older design here.
GOOD PRACTICES DOCUMENTS
A sub-section of the National pharmacovigilance system that lists the most important documents related to good pharmacovigilance practices for Argentina, only in Spanish.
LIST OF ANMAT FEES
How much does it cost to register imported medicinal products in Argentina? And how it differs for national products? Such questions can be answered using the table on the page linked below, though it’s only in Spanish.
PUBLIC ARCHIVE OF WARNING LETTERS
Hidden in a diferent part of the web than the inspections table, there is also a section of ANMAT website that publicly shares related warning letters to pharma companies that seem to breach drug regulations, only in Spanish.
INSPECTIONS LIST
A standalone portal listing inspections conducted by ANMAT including the very recent ones. Entries do not include much details, but still an interesting overview, only in Spanish.
MONTHLY PHARMACOVIGILANCE NEWS
Categorized by years and months, there is a comprehensive news archive of pdf files focused on both national and international pharmacovigilance news (on the page accessible by the link below, just click on the bubble with the year you are interested in).
GUIDES FOR ONLINE PROCEDURES
List of links to reporting processes instructions (for example related to RMP or PSUR) that are done through an online platform called TAD, only in Spanish.
Other interesting sections related to pharmacovigilance
If you are interested in annual data by the ANMAT pharmacovigilance department in the document format, look here (even though the most recent years are missing).
All important forms in one place.
Other important institutions & industry groups
MINISTRY OF HEALTH (MSAL)
The institution that oversees the entire healthcare system in Argentina, including public health policies, regulation, evaluation, and statistics collection.
Useful to know is that they regularly publish “Revista Argentina de Salud Pública” (Argentine Journal of Public Health), which can be viewed and downloaded using this subpage.
MSAL website: www.argentina.gob.ar/salud
CHAMBER OF PHARMACEUTICAL LABORATORIES (CILFA)
CILFA is an association that groups pharmaceutical manufacturers in Argentina and represents their interests.
What we like about their website is this page dedicated to the national pharma sector, where you can find interesting reports focused on the future of the industry. Some of them, like this one talking about perspectives of 2021 – 2025, are even available in English.
CILFA website: cilfa.org.ar
CHAMBER OF INNOVATIVE MEDICINES (CAEME)
A national group supporting and promoting pharmaceutical innovation, that is CAEME.
While visiting the website, be sure to check the page with “Weber Report“, which is a comprehensive report analysing pharmaceutical industry in Argentina from different angles. You can also download it as a pdf here.
CAEME website: www.caeme.org.ar
Some of the most important laws
Regulatory Framework and Administration
It outlines the main functions of the National Administration of Drugs, Food and Medical Devices (ANMAT).
Here you can find the most important information about registration of medicines.
Pharmacovigilance and Safety Monitoring
It lays out the conditions for import/export of medication.
Resolution No. 538/98 & Resolution No. 7439/99
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Argentina, following terms will be helpful for you to get familiar with:
SNFVG (Sistema Nacional de Farmacovigilancia)
→ National pharmacovigilance system
RAM (Reacción Adversa a Medicamento)
→ ADR / Adverse Drug Reaction
RFV (Responsable de Farmacovigilancia)
→ QPPV / Qualified Person for Pharmacovigilance
PGR (Plan de Gestión de Riesgos)
→ RMP / Risk Management Plan
IPAS (Informes Periódicos de Actualización de Seguridad)
→ PSUR / Periodic Safety Update Report
TAD platform (Trámites a distancia)
→ national platform for remote procedures (online reporting to authorities)
Is Qualified Person Responsible for Pharmacovigilance needed?
Yes, ANMAT requires pharmaceutical companies to designate a contact person responsible for pharmacovigilance activities.
Specifically, ANMAT Disposition 3870/1999 mandates that each pharmaceutical company appoints an employee (a professional) to serve as the contact person for all communications with the Department of Pharmacovigilance.
For further details about good pharmacovigilance practices in Argentina, we suggest you check this official pdf guide.
How can be adverse events reported in Argentina?
Adverse reaction reports can be submitted using online forms that are available on available on this ANMAT subpage.
The forms differ for healthcare professionals, patients and pharmaceutical companies. Reporting by email or a special portal is also possible (well described on the linked page).
Local medical journals to screen
Here are few examples of Argentine local literature that medical authorization holders should monitor:
LA PRENSA MEDICA ARGENTINA
One of the world’s most renowned journals in the field of medicine, published since 1914.
Publishes original research, reviews, commentaries, short communications, and editorials.
ISSN: 0032-745X
REVISTA ARGENTINA DE CIRUGÍA
The official scientific publication of the Argentine Association of Surgery (Asociación Argentina de Cirugía).
Aims to disseminate original contributions to knowledge in the field of surgery.
ISSN: 0048 – 7600
REVISTA ARGENTINA DE SALUD PÚBLICA
Already mentioned in the section about Argentine institutions, this is a journal published by the Ministry of Health (MSAL), so definitely good to put this authoritative literature on your screening list too.
ISSN: 1853-810X
REVISTA CIENTÍFICA ANMAT
A journal edited by ANMAT, published since 2017. Focused mainly on regulators of health products.
ISSN: 2796-7646
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
Book: Good Pharmacovigilance Practices in Latin America
Manual de Buenas Prácticas de Farmacovigilancia edición Latinoamérica
A free pdf to download with over 700 pages, linked also by ANMAT on their website. If you feel you would appreciate an extensive resource about pharmacovigilance not only in Argentina, but the overall region of Latin America, this is a book you might like.
Articles about regulatory requirements and policies
Pharmacovigilance Regulatory Requirements in Latin America
An article that analyses pharmacovigilance regulatory requirements across 21 countries in Latin America.
Pharmaceutical Policy in Argentina
A chapter about pharmaceutical industry and its regulations in Argentina.
Studies related to PV in Argentina
A study from Argentina that investigated the level of knowledge about pharmacovigilance and the activity of reporting an adverse event among local HCP, including dentists.
As mentioned in this analysis, University of San Luis was designated as “Peripheral Effector of the National Pharmacovigilance System” – the document is focused on ADR reports received there between years 2010 and 2013.
Adverse drug reactions as a reason for admission to an internal medicine ward in Argentina
Results from screening of 1045 patients, where probable ADR accounted for about 10% of admissions to an internal medicine ward.
RMP, PSUR and other documents related to reporting
If you plan a submission of RMP in Argentina, you can download related forms on this page.
Just as the previous link leads you tu the page related to RMP documents, this one lists PSUR sheets for download.
A table related to PSUR reporting, available in the forms section of ANMAT website.
A table related to ADRs detection, also from the forms section of ANMAT website.
Do you need some help with putting the Argentine PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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