The Anvisa Board of Directors approved, this Thursday (22), a resolution that simplifies some import rules for medicines and vaccines that combat mpox.
Wrongly popularized as ‘monkeypox’, the disease became the subject of a global emergency alert issued by the World Health Organization (WHO).
According to the Ministry of Health, the measure establishes the exemption from registration and gives “exceptional import authorization” for supplies acquired by the ministry for the prevention or treatment of mpox.
However, it only applies to drugs that have already been approved by other international regulatory authorities listed in the recently approved Collegiate Board Resolution (RDC).
The list includes authorities such as the WHO, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA/USA) and other regulatory agencies in Asia and countries that are references in health policies.
Anvisa’s resolution is provisional in nature and was unanimously approved by the regulatory agency’s board of directors.
Mpox in Brazil
According to data from the Ministry of Health, more than 700 cases of the disease were confirmed in Brazil in 2024.
THE CNN Health Minister Nísia Trindade ruled out the possibility of a pandemic of the disease in the country at this time, in an interview last Wednesday (21).
“This is a warning and it is very important to emphasize this, but it is not a situation that we should be alarmed about, in the sense of a pandemic,” the minister considered.
As Brazil has not yet registered cases of the 1B variant of the virus, which is a concern for the WHO, Nísia stated that there is no recommendation for mass vaccination against mpox. If adopted, immunization will be focused on specific groups and not on a large scale.
Although there is no prospect of vaccination, the Vaccine Technology Center (CTVacinas) at the Federal University of Minas Gerais (UFMG) is already awaiting authorization to begin the human testing phase of a national vaccine against mpox.
The vaccine had been in development for two years, since the first global emergency caused by the disease. In this new outbreak, this vaccine would come in response to the WHO’s appeal, which is trying to stop the spread of the virus among vulnerable migrant populations in northeast and southern Africa.
This content was originally published in Mpox: Anvisa simplifies rules for importing medicines and vaccines on the CNN Brasil website.
Source: CNN Brasil
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