Brasília – The National Health Surveillance Agency (Anvisa) has published a warning on its website. The warning concerns the rejections of drug registration requests.

Technical areas at Anvisa have found deviations in registration requests. These relate to the criteria of the Collegiate Board Resolution (RDC) 749/2022.

They also relate to the screening of requests for the Letter of Adequacy of the Active Pharmaceutical Ingredient Dossier. Both processes have directly impacted the increase in rejections of registration requests in Brazil.

Source: Anvisa