Anvisa stresses importance of pharmacovigilance and international collaboration

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Related tags: World health organization, Adverse drug reaction

Anvisa stresses importance of pharmacovigilance and collaboration
Brazilian drug regulator Anvisa has called for increased pharmacovigilance and more effective reporting of adverse reactions by authorities worldwide.

The National Health Surveillance Agency (Anvisa) made the comments at the 35th Annual Meeting of the participating countries of the Programme for International Drug Monitoring the World Health Organization (WHO) in Brasilia, Brazil this week.

Anvisa CEO Dirceu Barbano said there is a need to change the current paradigm of quality control of drugs. He suggested that while most countries have been quite strict at the time the product enters the market, surveillance of drugs already in use by the population needs improvement.

The Anvisa delegation also called for greater sharing of pharmacovigilance information between countries. Maria Eugenia Cury, head of national reporting at Anvisa said: “The drug trade is global, which requires action in all countries​.”

She argued that both the rapid identification of adverse events and subsequent sharing of information “is essential for countries around the world to make the necessary recommendations in relation to their populations.​”


Anvisa's address at the WHO meeting came just under a week after the organisation played host to 9th​ International Meeting of Pharmacovigilance of the Americas (IX EIFVA).

The event, which began last Thursday focused on collaboration to strengthen pharmacovigilance in the Americas and beyond.

In his address Barbano stressed the importance of thinking globally when monitoring drug quality, explaining that pharmacovigilance should not focus “within the borders of countries. We live in a world where goods are moving with increasing speed.​”

Anvisa also launched the 2nd edition of its Bulletin of Pharmacovigilance which details the rules that must be followed by companies in Brazil. Activites range from mandatory reporting of adverse events, to developing a framework capable of monitoring the safety of these products.

Related topics: Markets & Regulations, QA/QC

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