Brazil’s Anvisa approves new regulatory framework for low-risk drugs subject to notification
The Resolution RDC No. 576/2021 and the Normative Instruction No. 106/2021 expanded the list of drugs that may have simplified registration. The notification process aims to simplify the regularization of low-risk drugs.
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.
Anvisa approves the emergency use of antibodies for Covid-19 treatment
The indication for use is for mild and moderate Covid-19 cases in adults and pediatric patients (12 years and older) with laboratory-confirmed infection.
Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation
On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.
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 will begin monitoring prices of medical devices
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Anvisa signs agreement with European Medicines Agency (EMA)
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Guideline for Importation Process of Vaccines in Brazil
Material organized by Procomex brings description about the vaccine importation process into Brazil.
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.
Mexico’s Cofepris Modifies Pharmacovigilance Regulation: NOM 220-SSA1-2016
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.