ANVISA published today the Resolution (RDC) No. 348/2020, providing for the requirements and extraordinary and temporary procedures for the treatment of requests for registration of drugs, biological products, products for in vitro diagnosis, and post-registration change of both drugs and biological products due to the international public health emergency resulting from the new Coronavirus.
In cases of post-registration changes, this Resolution will apply, if the aforementioned products comply with the following requirements: (i) considered essential for the maintenance of life or used in case of serious health risk; and (ii) if the availability is threatened by imminent or installed shortages in the national market, due to the new Coronavirus.
Requests for registration of drugs and biological products, the Resolution will apply in case of specific therapeutic indication for the prevention or treatment of the disease caused by the new Coronavirus or in vitro diagnosis for SARS-CoV-2.
In addition to other measures, the Resolution authorizes the approval of requests, even if the completed necessary documentation is not submitted, by means of executing a Commitment Term, with subsequent supplementation of data and evidence.
We highlight that by the end of last week, ANVISA published a Resolution defining the requirements, extraordinary and temporary procedures regarding the certification of good manufacturing practices for registration and post-registration changes of active pharmaceutical materials, drugs and health products, due to the international public health emergency of the new Coronavirus.