Clipping of news on Brazilian Culture, Law and Citizenship
08/03/2015
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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Ahead of the National Health Surveillance Agency (Anvisa) two weeks ago, the public health physician Pernambuco Jarbas Barbosa became president of the agency advocating a health surveillance focused on risk probabilities, protecting the citizen, but has not prohibitive character or invasive in the lives of citizens.
In an interview to Brazil during the 11th Brazilian Congress of Public Health, Barbosa highlighted as challenges to his three-year term the approach of the agency with the population and the reduction of unnecessary bureaucracy in the sector. The president of the agency also announced that ANVISA may approve new rules to streamline the drug registration in Brazil.
New CEO of Anvisa, Jarbas Barbosa
In evaluating the CEO, Anvisa has developed a lot in 15 years of existence, but need to start using social networks to reach out to people, for example, to report on what remedies are not for sale or to what foods are being collected .
ANVISA is responsible for regulating directly or indirectly products account for 30% of gross domestic product (GDP), such as food and medicine. According to the new president, the agency has been increasing worldwide. Recently, Chile went automatically register generics with Brazilian registry. Paraguay and Colombia study do the same.
Registration remedies
"[The time for registration of medicines] is reasonable, but we can improve a few things," said Barbosa about time that the agency takes today to decide whether a remedy may or may not be marketed in the country. According to him, in August, the executive board of the agency may adopt a standard that will reduce the queue of four thousand million registration applications. He explains that this queue, as well as new drugs, there are also applications for packaging changes or number of tablets. The new standard will expedite the simplest procedures to vent the system.
According to Barbosa, to make the process faster is also necessary to look models agencies in other countries. "One example is that Brazil is one of the few countries where dietary supplements are treated as drugs. In most countries it is treated as food. " The classification in the evaluation of the president of the agency, overloads the area of medicines unnecessarily.
Coordinate the actions of the municipal, state governments and Union is another necessity of Anvisa, seen by Jarbas Barbosa as fundamental to strengthen the sector. To illustrate the situation, the new president of the agency says that the European Union recognized the quality standardization for Brazilian producers of raw materials for medicines, however, for the sale of products for European manufacturers, requires that inspections be done by the Union.
"We only have 35 producers of API (Active Pharmaceutical Inputs) in Brazil, faces the Anvisa do [inspections]. But we want to extend this recognition to drug producer, which are 350, we have to settle with the states a clear division, "he said.
Dengue
One of the most important topics on the agenda Anvisa is the decision to release the first vaccine against dengue. The product is being completed and the agency will have to decide whether the vaccine may or may not be marketed in Brazil. The Sanofi Pasteur laboratory, responsible for the product, announced that the decision is expected later this year, but Barbosa does not confirm the deadline.
"Today we have exchange files with other agencies, and this helps in the analysis. In the case of dengue we are starting from scratch. " Barbosa says that the issue of dengue vaccine is so complex that the World Health Organization is organizing a meeting between regulatory agencies to establish a parameter for product registration.
Read Mais:http://economia.estadao.com.br/noticias/geral,pela-1a-vez--financiamento-de-carro-usado-jovem-ultrapassa-o-de-zero-km--imp-,1736901
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Source: JB Online
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This article was translated by an automatic translation system, and was therefore not reviewed by people.