The Federal Commission for Protection against Health Risks (COFEPRIS) announced the elaboration of two guidelines on prior requirements to the submission of marketing authorizations, one guide for medical device applications and the other for drug applications.

These guidelines are expected to facilitate, standardize and keep updated the criteria for the integration of information into the dossier of these health supplies, to make their content much clearer, and to speed up processes and response and approval times for these applications by the regulatory authority.