Pharmacovigilance in Mexico
How is it with the drug safety system in the “Land of the Aztecs”? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Mexican pharmacovigilance services:
Designated Person for PV in Mexico
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Mexico?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Mexico is the Federal Commission for Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).
This agency, headquartered in Mexico City, operates under the Mexican Secretariat of Health (Secretaría de Salud) and is responsible for regulating drugs, medical devices, and monitoring adverse drug reactions.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website indicates that an English version is available; however, in practice, there are very few translated pages, and the menu is not translated at all.
We recommend using the website in its original Spanish version and utilizing a translation tool. This approach will significantly increase your chances of finding the information you need.
Interesting website sections related to pharmacovigilance
DOCUMENTS REGARDING PV
Classical page on pharmacovigilance does not offer any interesting information, but here any many documents that may come in hand, such as guidelines, guides or regulations.
PLATFORM FOR PROCEDURES
As it seems there four different modules, one of which is for registrating new medicines (medicamentos), there is also a video guide how to proceed.
THERAPEUTIC EXPANSION
Biweekly report on therapeutic expansion that shares an easy-to-read list of approved medicines and medical devices, the newest report is at the bottom.
COFEPRIS SCIENCE
This journal focuses on science that tackles health risks and aims to make knowledge accessible to everyone, issues are available on the linked page in PDF, accessible only in Spanish.
Other important institutions & industry groups
SECRETARIAT OF HEALTH (SSA)
The SSA is the primary government body responsible for public health policy and the overall management of the healthcare system. It oversees various health programs and initiatives aimed at improving the health of the Mexican population.
The website is currently undergoing maintenance, so it might happen that some pages won’t be accessible. From those interesting parts of the site, we can mention the Documents section you can find Epidemiological Surveillance of many areas, such as Maternal Deaths or Acute Respiratory Infections.
Secretariat’s website: https://www.gob.mx/salud
MEXICAN ASSOCIATION OF PHARMACEUTICAL RESEARCH INDUSTRIES (AMIIF)
AMIIF represents over 60 companies involved in pharmaceutical research and biotechnology. This association is dedicated to the development of new medicines and therapeutic options, emphasizing innovation and clinical research
Probably the most interesting thing on their site is the “70 years book – A STORY OF INNOVATION”, which explores key pharmaceutical advances in six vital areas: vaccines, antibiotics, cardiovascular disease, diabetes, cancer, and HIV/AIDS, accessible in English. They also have their blog with many articles on various topics and if youu want to stay in the picture, then when you scroll all the way down on their home page, you can subscribe to their newsletter.
AMIIF’s website: https://amiif.org/
NATIONAL ASSOCIATION OF DRUG MANUFACTURERS (ANAFAM)
ANAFAM represents the interests of pharmaceutical manufacturers in Mexico, focusing on promoting the development and competitiveness of the industry.
Sadly, their website is truly empty, basically the only thing that you can read about is their mission and vision. There is page dedicated to news in the industry, but it’s literally empty, sou let’s hope there will be somtehing interesting one day.
ANAFAM’s website: https://anafam.org.mx/inicio
Some of the most important laws
Basic legislation
General Health Law (Ley General de Salud)
This is the primary law that establishes the legal framework for health regulation in Mexico.
Regulations of the General Health Law on Health Supplies (Reglamento de Insumos para la Salud)
These regulations, issued by the Ministry of Health, provide more detailed requirements for the regulation of health supplies, including medicines.
Official Mexican Standards
NOMs are technical regulations issued by COFEPRIS that establish standards for various aspects of health regulation, such as NOM-220-SSA1-2016: Installation and operation of pharmacovigilance. Other NOMs can be found here.
Guidelines
COFEPRIS has issued various guidelines to provide more practical guidance on implementing pharmacovigilance requirements.
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Mexico, following terms will be helpful for you to get familiar with:
NOM (Normas Oficiales Mexicanas)
→ technical regulations issued by COFEPRIS
SRAM (Sospechas de Reacciones Adversas)
→ suspected adverse reactions
EA (Eventos Adversos)
→ adverse events
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)
→ Federal Commission for Protection Against Sanitary Risks / main authority on pharmacovigilance
CNFV (Centro Nacional de Farmacovigilancia)
→ National Pharmacovigilance Center
Is Qualified Person Responsible for Pharmacovigilance needed?
According to the Mexican Official Standard NOM-220-SSA1-2016 on the Installation and Operation of Pharmacovigilance, each pharmaceutical unit involved in pharmacovigilance activities must have a designated person responsible for pharmacovigilance. This individual is required to be the sole valid interlocutor for COFEPRIS on matters related to pharmacovigilance.
How can be adverse events reported in Mexico?
Reports can be submitted directly to the Federal Commission for Protection Against Sanitary Risks (COFEPRIS). Healthcare professionals and companies can report ADRs through this online platform.
More inforamtion on how to report ADRs can be found here.
Local medical journals to screen
Here are few examples of Mexican local literature that medical authorization holders should monitor:
REVISTA MÉDICA DEL INSTITUTO MEXICANO DEL SEGURO SOCIAL
This journal focuses on publishing original research and reviews related to health and medical practices within the Mexican Social Security Institute.
It is a valuable resource for healthcare professionals seeking insights into public health policies and clinical practices in Mexico.
ISSN: 2448-5667
SALUD PÚBLICA DE MÉXICO
A bilingual journal that publishes articles on public health topics, providing a platform for discussions on health policies and epidemiological research.
Its international reach and rigorous peer-review process make it essential for anyone interested in public health advancements.
ISSN: 1606-7916
GACETA MÉDICA DE MÉXICO
This journal covers a wide range of medical topics, including clinical research, medical education, and public health issues, making it a comprehensive source for healthcare professionals.
It aims to disseminate knowledge that can improve medical practices and patient care in Mexico.
ISSN: 2696-1288
MEDICINA UNIVERSITARIA
This journal publishes research articles, reviews, and case reports primarily from academic institutions in Mexico, focusing on medical education and clinical practice.
It is particularly useful for students and educators looking to stay updated on medical advancements and educational methodologies.
ISSN: 2954-3495
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
Scientific publications regarding pharmacovigilance
A Narrative Review of Pharmacovigilance: Report of Adverse Drug Reactions in Mexico
This study dives into the complexities of how drugs interact with our bodies, revealing that while newer medications may be more powerful, they don’t necessarily come with a safety guarantee. It highlights the significant gap in reporting adverse drug reactions in Mexico, uncovering the challenges physicians face and emphasizing the urgent need for better communication and support to improve patient safety.
You’ll explore how Mexico is enhancing its pharmacovigilance system through the successful implementation of advanced reporting tools like VigiFlow and VigiLyze, which have significantly improved the quality and quantity of adverse drug reaction reports.
Reveal how a targeted training program on pharmacovigilance transformed the attitudes of healthcare professionals in a public hospital in Mexico, leading to a significant increase in the reporting of adverse drug reactions.
interesting resources
Key actions taken by this health agency to safeguard public health are being discussed in this podcast, you can listen to it on Spotify and on the linked page there is also a list of episodes.
This page contains basic staticsits about Mexcio in various fields such as Population, Life expectancy or Health statistics.
Do you need some help with putting the Mexican PV System together? We’re here for you.
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…consider also our global end-to-end PV solution!
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