Snapshot

The Equivalencia 2025 - Proposed in Public Consultation pathway has been developed by the of Mexico.

This pathway can be used where a) Medicines: i. New Molecular Chemical Entities, according to definition of Art 2, section 15 of the Regulation for Health Inputs; ii. Generics; iii. Biotechnological innovative and iv. Biotechnological biocomparable. b) Medical Devices described in Art 262 of General Health Law .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is 60 work days.