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.
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.