According to the regulatory agency, the order was requested on the day August 2 and is already under analysis by the technical team. Previously, Anvisa had already applied for registration of the company Biomédica. The request was analyzed and the regulator issued a requirement, which is a request for information and data necessary for the conclusion of the analysis by the technical team.
The registration process involves evaluating fabrication, reliability of results and diagnostic effectiveness.
According to Anvisa, currently the diagnosis of monkeypox in the country is made through molecular PCR assays with a methodology developed by the clinical analysis laboratory itself, based on validated protocols. This form of action is regulated and is equivalent to that applied by different countries, especially when there is an epidemic caused by emerging etiological agents.
Situation in the country
According to data from the Ministry of Health, until yesterday (5), 2004 cases of monkeypox were recorded in the country. The folder accompanies another 1,962 cases. So far, one death has been confirmed by the disease in Minas Gerais.
The Minister of Health, Marcelo Queiroga, announced at the beginning of the week that Brazil will receive, through the Pan American Health Organization (PAHO), the antiviral Tecovirimat to “strengthen the fight against the outbreak” of monkeypox.