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’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.
Brazil’s Anvisa is approved for Pharmaceutical Inspection Co-operation Scheme – PIC/S
Brazil’s ANVISA has completed the process of joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Agency will become the 54th member of the international pharmaceutical inspection initiative.
Registration Of COVID-19 Rapid Tests with Brazil’s Anvisa- Required Documents
Anvisa published the Resolution (RDC 348/2020) to speed up the evaluation of new products for detection of the new coronavirus (SARSCoV-2). Check out GRP’s blog on all the required documents necessary to register COVID-19 rapid tests with Brazil’s Anvisa.
Anvisa Introduces Pilot Program to Increase Quality of Health Products
Anvisa instituted the Pilot Program to Expand the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products classes III and IV in the country.
Brazil’s Anvisa Certificate of Good Manufacturing Practices
The Certificate of Good Manufacturing Practices is the document issued by Anvisa attesting that a certain establishment complies with Good Manufacturing Practices.