MEXICO
April 17, 2015
Since 9 February 2015, new guidelines apply in Mexico for the approval and renewal of Biologics.
The Mexican Official Standard Rule NOM-257-SSA1-2014 for Biologics entered into effect. In addition to reinforce those provisions already existed in the Mexican Law to guarantee safety, efficacy and quality of biologics, it confers to the Evaluation Subcommittee on Biotechnological Products the authority to evaluate the data related to clinical trials, approval or renewal of innovator biologics and to evaluate the characterization of biologics as innovators, reference or bioequivalent products.