Changes for new and generic medicines
The recent publication of resolution (RDC) 60/2014 updates and harmonizes the technical criteria of quality, safety and efficacy for the registration of drugs classified as new, generic and/or similar. The rule replaces Resolutions RDC No. 136/2003, 16/2007 and RDC No. 17/2007.
As a starting point for the harmonization and updating of standards, the resolution takes into consideration ongoing problems that were not addressed by existing regulation. This change also was required for the implementation of the electronic drug register of the Brazilian Health Surveillance Agency (ANVISA).