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.
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.
Brazil’s Anvisa authorizes melatonin in food supplements
The approval of Melatonin as an acceptable ingredient in food Supplements occurred through the amendment of Normative Instruction (IN) No. 28/2018,
Brazil Regulatry Breakdown: Food supplement or specific medicine?
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, there is still confusion about the framing and registering the products in brazil ; is it a Food Supplement or is its a specific medicine?
Brazil’s Anvisa is accepted into International API Inspection Program
Anvisa is accepted as a member of the international API Inspection Programs.
Brazil’s Anvisa releases a new Adverse Event Notification Form
Brazil’s Anvisa introduces new tool enables faster and easier notification of drugs and vaccines.
Anvisa allows the regularization of Radiopharmaceuticals via Notification Process
Following Resolution No. 451/2020 that came into effect in February 2021, Anvisa regulates radiopharmaceuticals exempt from registration upon notification process.
Anvisa publishes new Technovigilance Manual 2021
The new Technovigilance Manual improves health regulation to meet the challenges posed by new technologies and the speed with which reality is changing.
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.
Guidebook on Requesting Emergency Use of Drugs for Covid-19
The guideline describes the minimum technical requirements to be presented by the companies for temporary Authorization for Emergency Use of drugs for Covid-19.
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.
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.