PANDRH & Latin America
PANDRH — Pan American Network for Drug Regulatory Harmonization
PANDRH (Red Panamericana para la Armonización de la Reglamentación Farmacéutica) is a regional regulatory harmonisation network operating under the Pan American Health Organization (PAHO), the regional office of the World Health Organization (WHO) for the Americas.
COFEPRIS is an active member of PANDRH, which:
- Promotes regulatory convergence among health authorities across Latin America and the Caribbean.
- Develops harmonised technical guidance for medicines, biologics, and medical devices.
- Facilitates regulatory information sharing between member states.
- Supports capacity building for smaller regulatory authorities in the region.
Mexico's position in Latin America
COFEPRIS is one of the most mature regulatory authorities in Latin America, alongside Brazil's ANVISA and Colombia's INVIMA. As such, a COFEPRIS sanitary registration is often seen as a mark of quality and is used as a reference by other Latin American regulators.
Key aspects of Mexico's regional position:
- COFEPRIS as a regional gateway — many manufacturers seeking to expand across Latin America prioritise Mexico first, as the COFEPRIS regulatory package is often reusable as a reference dossier for other markets.
- ANVISA recognition — Brazil (ANVISA) and Mexico (COFEPRIS) have a mutual information-sharing arrangement. A COFEPRIS registration is not automatically recognised by ANVISA, but the COFEPRIS technical dossier and regulatory documentation can serve as source material to reduce duplicative testing and serve as a reference for the ANVISA submission, potentially accelerating the Brazil registration timeline.
- Regional harmonisation progress — PANDRH is working toward greater alignment of IVD classification and device registration requirements across the region.
Other major Latin American regulators
| Country | Regulator | Key notes |
|---|---|---|
| Brazil | ANVISA | Second largest market; separate registration; complex dossier |
| Colombia | INVIMA | CE Mark or FDA clearance assists; registration required |
| Argentina | ANMAT | Risk-class registration system; CE/FDA assists |
| Chile | ISP | Class-based registration; CE Mark widely referenced |
| Peru | DIGEMID | Registration required; alignment with international standards growing |
Multi-market strategy: Using COFEPRIS as a LATAM platform
A COFEPRIS registration cannot be directly transferred to other LATAM markets, but the dossier and documentation prepared for COFEPRIS — particularly under the standard route — is directly usable as source material for ANVISA, INVIMA, ANMAT, and other LATAM submissions.
See Multi-market submission strategy.