Overview
Pharmacovigilance is essential to ensure that medicines marketed in Brazil continue to be safe and effective over time. Even after approval and market entry, these products continue to be monitored through a structured cycle that involves detecting adverse events, analyzing risks and adopting corrective measures. In this blog, you will understand how this process coordinated by ANVISA works, what the roles of each agent involved are and why the participation of society is so important.
Introduction
The safety of medicines available on the market is a priority for ANVISA (the National Health Surveillance Agency). To ensure that the benefits of medicines continue to outweigh the risks throughout their use by the population, the Agency coordinates the so-called pharmacovigilance cycle – a set of continuous actions aimed at identifying, evaluating, understanding and preventing adverse effects or other problems related to medicines.
But how does this cycle work in practice? And what is the role of ANVISA, the pharmaceutical industry, health professionals and patients themselves in this process.
Pharmacovigilance is an activity regulated in Brazil by RDC No. 406/2020, which deals with Good Pharmacovigilance Practices for drug registration holders. This practice involves systematically monitoring the safety of medicines after they have been authorized for marketing, i.e. during the so-called post-marketing phase.
Although drugs are extensively tested during clinical trials, these studies have limitations: they have a small number of participants, limited duration and strict inclusion criteria. Thus, it is only after large-scale use that rare adverse reactions, unexpected drug interactions and other potential risks can be identified.
Pharmacovigilance Cycle
The pharmacovigilance cycle involves several stages:
Detection – The initial stage is the identification of possible adverse events and problems related to the use of medicines. These events can be reported by health professionals, patients, industry or even detected through scientific literature and international databases.
Notification – In Brazil, this information is recorded in the VIGIMED system, a digital platform for notifying adverse events and technical complaints. The active participation of society is essential to feed the system.
Analysis and Evaluation – ANVISA, together with the registration holders, analyzes the data received to identify signs of safety. Causality analyses and risk-benefit assessments are carried out.
Decision-making – If a risk is confirmed, ANVISA can adopt measures such as: changing the package leaflet, restricting use, sending letters to health professionals or, in more serious cases, suspending the batch or canceling the registration.
Monitoring and Communication – Corrective actions are monitored and communicated to the public and international authorities, promoting transparency and reliability in the Brazilian regulatory system.
Working of the systems
ANVISA: coordinates the national pharmacovigilance system, establishes guidelines, assesses risks and adopts regulatory measures.
Pharmaceutical Industry: must maintain its own pharmacovigilance systems, carry out internal investigations and report events to ANVISA.
Healthcare professionals: work on the front line of detecting and reporting adverse events.
Patients and caregivers: are encouraged to report suspected adverse reactions directly to VIGIMED.
Importance for public health
The Brazilian pharmacovigilance system is one of the pillars of health safety and contributes directly to the rational use of medicines. Continuous and integrated action by the various players makes it possible to identify risks early on and prevent major damage to the population’s health.
ANVISA also participates in international networks, such as the WHO-Uppsala International Monitoring Program, which strengthens the exchange of information and global surveillance.
Pharmacovigilance is a dynamic and essential process for guaranteeing the efficacy and safety of medicines used in Brazil. Through the cycle of monitoring, evaluation and response, ANVISA ensures that medicines remain safe throughout their life cycle. The active participation of all those involved – industry, professionals and patients – is fundamental to the success of this system.
Conclusion
The safety of medicines does not end when they are approved for sale. Through pharmacovigilance, ANVISA ensures the continuous monitoring of risks, promoting evidence-based decisions and protecting the health of the population. Collaboration between industry, health professionals and citizens is vital for an effective surveillance system. By reporting adverse events, we all contribute to a safer and more transparent market, where the rational use of medicines is a permanent priority
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
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References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.