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February 9, 2022
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Anvisa will hold public consultation on review of regulations in Mercosur

Anvisa will hold public consultation on review of regulations in Mercosur

The National Health Surveillance Agency (Anvisa) will open, for 60 days on a date to be announced, a public consultation aimed at the manifestation of society on the planned revision of the technical regulation that covers clinical trials within the Mercosur.Anvisa will hold public consultation on review of regulations in Mercosur

The decision was unanimously approved today (9) during the 2nd Ordinary Public Meeting of the Collegiate Board of Directors.

Today’s meeting enabled “the most important advance for clinical research” in the Mercosur region, in the assessment of director Meiruze Sousa Freitas, who was responsible for reporting on the proposal for a public consultation to review the Mercosur Technical Regulation on Clinical Trials with Medicines , Biological Products and Medical Products.

Meiruze said that, upon opening the consultation, Anvisa will advance towards harmonizing, in Mercosur, regulations that cover the area of ​​medicines and products for the health of its citizens.

She recalled that there is only one resolution in force within the framework of the Mercosur regulatory framework – an “old and outdated technical regulation on clinical research”. She, however, defended that, in the name of the autonomy of each member state, the proposal guarantees the existence of local devices.

Fake news and vaccination

When opening the 2nd Ordinary Public Meeting of the Collegiate Board, the president of Anvisa, Antônio Barra Torres, regretted the situation of overcrowding observed in hospitals, by “people who chose not to be vaccinated”. “This problem is exacerbated with our children, where the effects of the criminal action of those who divulge fake news they have severely impeded the vaccination of our children”, he said.

“This evil is unfortunately already done, and the result of it is there, [reforçado] with a slow-moving vaccination campaign. And it is having consequences, with the death toll among children of an age likely to be vaccinated soaring,” she added.

Death of health professionals

Torres also regretted the increase in cases and deaths of health professionals, due to covid-19. “Unfortunately, in our country, four out of five doctors have had covid-19 in recent months. Brazilian health teams are exhausted and working beyond limits and strength. They are doing their duty and they are dying too.”

“While voices say that the Ômicron variant is mild and less serious, these same voices forget to mention in which context this lightness or mildness occurs. This context is the context of each country, system or healthcare team available to treat patients. Brazil unfortunately entered the range of thousands of people killed in 24 hours by covid-19. That equates to five, four or three planes crashing every day,” he argued.

Federal government

Yesterday (8), the Minister of Health, Marcelo Queiroga, said that the government has made efforts not only to ensure that vaccines reach states and municipalities, but also to reassure parents about the effectiveness and safety of immunizers.

According to a balance sheet released yesterday by the minister, the percentage of children aged 5 to 11 who took the first dose of immunization against covid-19 is less than 15%.

For the minister, it is natural that the immunization of children does not advance at the same speed as that of adults. “Vaccinating a child is not like vaccinating an adult. Sometimes you have to convince them. No one is going to take a child by force and vaccinate him while he is crying.”

Still in response to questions about the delay in vaccinating the children’s audienceQueiroga demanded more commitment from the states and municipalities.

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