Snapshot

The Article 170 pathway has been developed by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) of Mexico.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA Egypt Europe Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO

COFEPRIS must decide on the application for a sanitary approval within a maximum period of 60 working days counted from the day following that in which the applicant delivers the applicable documentation. After the aforementioned deadline, if COFEPRIS has not responded, it will be understood that it has reached a negative decision.