capas regulatory affairs - rdc 675-22

RDC 675/22

The new RDC 675 came into force in March 2022, which deals with the adequacy of drugs registered until June 2, 2003 and which did not present evidence of therapeutic equivalence at the time of registration.

According to ANVISA, RDC 675/22, which revokes RDCs 134/2003, 210/2004, 37/2011 and 98/2016, comes with the aim of revisiting pharmaceutical formulations in order to guarantee quality control, proving pharmaceutical equivalence and relative bioavailability assays.

So, if you are an entrepreneur in the health market within the pharmaceutical area, fit into this RDC and need support to be regular with ANVISA, count on our team of experts!

Contact us!

-> regulatory@enzytec.com

-> +55 31 99145-9259


Any questions? Contact us and you will be answered soon!