Snapshot

The Recognition of MAs from Reference Authorities pathway has been developed by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) of Mexico.

It is an abridged review (a reliance pathway).

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

COFEPRIS must issue its opinion within 60 working days, starting from the day following the registration request day. If there is no manifestation within this period, it must be understood that the opinion is negative. The requirements will be issued within 20 working days for administrative data and 40 working days for technical aspects. The revision period is suspended pending the response from the marketing authorization holder and if the marketing authorization used as a reference is canceled or suspended, the registration holder must notify COFEPRIS within 5 working days