Interfarma contributed to Public Consultation no.1039, conducted by Anvisa for the adoption of an optimized analysis procedure.
The Agency’s proposed resolution determines the general criteria for taking advantage of the analysis carried out by an Equivalent Foreign Regulatory Authority. The Brazilian agency has been adopting reliance measures – a practice based on reliable information from qualified regulatory authorities – to accelerate the analysis steps carried out by its technical staff.
Reliance adoption is a long-standing demand of Interfarma and the pharmaceutical sector. The Association and its associates support the adoption of optimized analysis procedures and believe that this will be important to improve the efficiency and time of the analyses performed by the Agency’s technical staff. The pandemic has advanced the discussion of reliance and in the evaluation of Interfarma it is very positive that the agency has carried out the public consultation to receive contributions from different sectors.
Reliance will allow Anvisa to make use of the analysis made by other agencies and shows that the Agency works in accordance with the main regulatory agencies in the world.