Mexican Regulators Streamline Drug Registration Process

• Mexican regulators now allow drug registrants to submit product modification and renewal applications simultaneously.
• It is anticipated that COFEPRIS will eventually extend this allowance to medical device registrants.
• If extended to medical devices, the COFEPRIS allowance would streamline manufacturers’ obligations to obtain registration renewals and approvals for product changes.

Recent changes to modification and renewal requirements for drug registrations in Mexico may soon apply to medical devices as well.

Mexico’s medical device and pharmaceutical regulator, COFEPRIS, has published - http://dof.gob.mx/nota_detalle.php?codigo=5472489&fecha=21/02/2017 new allowances for drug applications to combine product modifications and renewals. Rather than submitting modifications such as changes of manufacturing site, commercial name, registration holder, or therapeutic indication separately to COFEPRIS, drug manufacturers may now submit changes simultaneously with applications to renew their product registrations.