Brazil’s Anvisa produces new committee for the accelerated submission of COVID-19 related clinical trials.
Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19.
Brazil’s Anvisa publishes Service Orientation (OS) that may provide simplification of clinical trial applications (DDCM)
Anvisa pusblishes Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE drugs or placebos.
Colombia’s Invima modifies administration measures due to COVID-19 pandemic
Invima changes the transitional administrative measures under Resolution 2020012926 of 3rd April 2020 due to COVID-19
Brazil’s CMED urges Covid-19 pharmaceutical companies to Apply Minimum Discount
In Brazil, drugs and pharmaceuticals must follow “the minimum discount rule” of the Drugs Market Regulation Chamber (CMED) for public procurement of drugs and pharmaceuticals inputs
Brazil’s Anvisa updates conduct of clinical trials with Technical Note 22/2020
Anvisa publishes a Technical Note 22/2020 updating the guidelines for sponsors, research centers and investigators involved in conducting clinical trials.
Webinar: Brazil Cosmetic Regulatory Compliance and Importation Requirements
GRP has teamed up with ChemLinked to bring you a webinar on Cosmetic Regulation and requirements in Brazil. The webinar will introduce the Brazilian cosmetic market, then specify the cosmetic regulatory framework, including cosmetics registration, labeling, and advertisement, and finally outline regulatory requirements for the importation of cosmetics into Brazil
Brazil’s Anvisa outlines Pharmaceutical Registration Exceptions due to COVID-19
Anvisa has published a Resolution RDC Nº 392 2020, that defines the criteria for the application of exceptions to Good Manufacturing Practices and Import requirements for drugs and pharmaceutical during COVID-19.
Brazil’s Anvisa Registration Requirements for COVID-19 Rapid Test
On May 14, 2020 Brazil’s Anvisa published information on the requirements of the registration of the rapid tests for COVID-19 in Brazil.
Brazil’s ANVISA issues new Resolution for the direct import of products by Healthcare Centers
On May 12, 2020 ANVISA published new resolution RDC Nº 383 that addresses the direct import of products by health centers.
EMA waives GMP inspection fees during COVID-19
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.
Registration of Biologics in Brazil
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.
Brazil’s Anvisa Updates medical device regulations during COVID-19 pandemic.
Anvisa’s updated regulation RDC 379/2020 provides requirements for medical device manufactures and identifies devices eligible for priority importation.