The National Health Surveillance Agency (Anvisa) decided to create a Technical Committee for the Monkeypox Emergency (monkey pox) so that the technical areas of clinical research, registration, good manufacturing practices, pharmacovigilance and advanced therapies work in a collaborative process , including health professionals and the scientific community.
The expectation is that this committee will bring together the best experiences available in regulatory authorities, allowing for the acceleration of development and actions involving clinical research and authorization of medicines and vaccines.
“The technical team will provide guidance on clinical trial protocols and discuss with developers guidance on clinical trials of drugs intended to treat, prevent or diagnose the disease causing the public health emergency. The purpose of these guidelines for developers, including academics, is to enable the rapid approval and conduct of well-designed tests, so that they can provide robust data needed for decision-making and avoid duplication of investigations.
Which is
Monkeypox is a disease caused by infection with the Monkeypox virus, which causes smallpox-like symptoms. This illness begins with fever, headache, muscle aches, exhaustion, and swollen lymph nodes. A rash usually develops one to three days after the fever starts, first appearing on the face and spreading to other parts of the body, including the hands and feet. In some cases it can be fatal, although it is typically milder than smallpox.
The disease is transmitted to people by various wild animals such as rodents and primates, but it can also be transmitted between people after direct or indirect contact.
Historic
On July 23, 2022, monkeypox was classified by the World Health Organization (WHO) as a Public Health Emergency of International Concern (ESPII).
Since the beginning of the recent smallpox outbreak, Anvisa has monitored the situation, including guiding actions in the area of ports, airports and borders, issuing technical notes to guide health services and blood donation.
