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- Argentina’s ANMAT and Brazil’s ANVISA carry out first secure data exchange
Argentina’s ANMAT and Brazil’s ANVISA carry out first secure data exchange
Brazil’s National Health Surveillance Agency (ANVISA) this week announced that it used for the first time the Regulatory Information Secure Exchange (RISE) in the end of last year to exchange medical device inspection registration data with Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT). RISE is part of the Regulatory Exchange Platform-secure (REPS), which was created by the Pan American Health Organization (PAHO) and National Regulatory Authorities (NRAs) in the continent to exchange private documents, and is aimed at streamlining processes and boosting regulatory convergence.
ANVISA also announced a collaboration agreement signed with the French National Agency for Medicines and Health Products (ANSM) for the exchange of information on health products, including policies, practices, standards, laboratory tests, pre-registration evaluations, post-marketing pharmacovigilance, compliance evaluations, as well as clinical trials and therapies regulations.