Brazil’s Anvisa expands the Authorization for Clinical Trials with Medicines in Brazil
Amendment of Resolution No. 9/2015, which provides for clinical trials with medicines in Brazil, allows, on an emergency and temporary basis, the use of analyses performed by foreign authorities that are members of the ICH.
Brazilian Ministry of Health will train professionals to identify patients with rare diseases
Among the actions the Brazilian Federal Government will offer a free training course on the subject, in addition to the campaign mascot calling attention to diagnosis and information on the subject.
Distribution Process of the Covid-19 vaccines in Brazil
From the lab to the arm: learn about the Ministry of Health’s Covid-19 vaccine trial in Brazil.
WHO approves emergency use of CoronaVac, Butantan Institute’s vaccine against Covid-19
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Anvisa approves clinical study with advanced therapy product against Covid-19
Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
NMPA publishes new guideline for faster approval of Medical Device
China’s State Council publishes a new Medical Device Regulation (Order no. 739) to follow conditional approvals on rare diseases treating medical devices
FioCruz reinforces the position adopted by Anvisa, EMA and WHO on vaccine safety
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Anvisa’s role in monitoring adverse events during immunization – Covid-19
Brazil’s EUA procedure assesses the suitability of Covid-19 vaccines for use during the current public health emergency to minimize.
Anvisa Approves Unanimously the Emergency Use of Vaccines
Brazil’s EUA procedure assesses the suitability of Covid-19 vaccines for use during the current public health emergency to minimize.
Anvisa is evaluating two requests for emergency use of vaccine
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.
Brazil’s Pharmacovigilance: The Program of Risk Management and Pharmaceutical Technology of Vaccines
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.
Brazil’s Anvisa defines requirements for requests for emergency use of vaccines
A guide prepared by Anvisa provides guidance to development companies on procedures for emergency use authorization of Covid-19 vaccines.