Brazil – Anvisa Resolution RDC 348/2020 with Alternative Procedures for Registration of Medicines, Biological Products and In Vitro Diagnostic Products Due to COVID-19 Epidemic

​The Anvisa (Brazilian Health Agency) issued the Resolution RDC 348/2020 with extraordinary and temporary criteria and procedures for the treatment of requests for registration of medicines, biological products and products for in vitro diagnosis and post-registration updates of medicines and biological products due to the emergence of international public health resulting from the new Coronavirus. The Anvisa Registration may be granted under the terms of this Resolution when the specific therapeutic indication for the prevention or treatment of the disease caused by the new Coronavirus (COVID-19) or in vitro diagnosis for SARS-CoV-2 is configured. The Resolution RDC 348/2020 is valid for 180 days after its publication date in the Official Gazette, March 18th 2020.