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.
Australia’s TGA GMP inspections during COVID-19
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts of on-site inspection of GMP clearance.
Brazil’s Health Authority requires Registration Holders to send daily information to ANVISA regarding drugs necessary in COVID-19 Pandemic
Companies that hold drug registrations must provide Anvisa daily information about the manufacture, import and distribution of anesthetics, sedatives, neuromuscular blockers and adjuvant agents, among other drugs used to maintain the lives of patients infected with the new coronavirus (Sars-CoV-2).
China’s NMPA introduces new guidance for COVID-19 drug clinical trials
China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.
United Kingdom’s MHRA releases a list of exempted medical devices
United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.
Steps to take if you have a COVID-19 confirmed positive worker: CDC Recommendations
The FDA encourages and outlines major steps to be taken as per the CDC recommendations to help prevent and slow the COVID-19 in the office.