Directors of Regulatory Authorities in Central America oversight on effective solutions to address countries´ challenges in health regulation

10 Jun 2022
Reunión de directores de las ARNs de Centroamérica

Washington, DC, 10 June 2022 (PAHO/WHO) - Nicaragua hosted the meeting of National Regulatory Authorities directors and technicians from Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama, to update the status of the joint evaluation of dossiers and determine future actions for its implementation.

The mechanism for the joint evaluation of dossiers is a process through which representatives of the participating States Members form a commission to verify and decide whether the evaluated medicine meets the application criteria of the Central American Technical Regulations. This process finishes by obtaining a unique technical review that must be attached to the health registration process of each participating country.

The Join Evaluation Mechanism of dossiers for product registrations contributes to the regulatory strengthening of the Central American Region since it brings the countries together in an effort to integrate the processes and criteria for the evaluation of medicines dossiers to access the Central American market.

During the meeting, representatives discussed the regulatory strengthening effort and its importance in helping to improve access to safe and effective medicines. As part of the agreements, it is expected to specify the next steps to ensure a review with the highest technical standards to contribute and guarantee access to safe and effective medicines for the Central American Region. Regulatory authorities from Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama participated in the meeting.

PAHO provides technical assistance to Member States, facilitating processes that allow regulatory authorities to achieve their goals. Likewise, it collaborates with the Member States of Central America in regulatory strengthening, using the Global Evaluation Tool and technically accompanying the Institutional Development Plan of the national regulatory authorities and technically coordinates the evaluation procedure of medicines dossiers.