Snapshot

The Equivalence Agreement pathway has been developed by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) of Mexico.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Switzerland United States

Requirements and time frames vary among new molecules, biologicals and follow-on products. Article 166 of the Health Law Regulations sets out the following approval time frames: 180 calendar days for medicines that include an active pharmaceutical ingredient or therapeutic indication already approved in Mexico; 240 calendar days for medicines approved abroad but not in Mexico; and 180 calendar days for new drugs (a meeting with the New Molecules Committee is required). The approval time frame for biologicals and biosimilars is 180 calendar days (articles 177 and 177-bis 4 of the Health Law Regulations). *These time frames may vary in practice, but can be reduced if the application has been pre-examined by a third examiner (private company) approved by COFEPRIS to do so.