Regional Forum for Regulators of Clinical Trial Oversight

The XI Conference of the Pan American Network for Drug Regulatory Harmonization (PARF Network) recommended strengthening the technical capacities of National Regulatory Authorities (NRAs). To this end, the Regional Forum of Regulators was formed to oversee clinical trials.

Objectives:

Exchange experiences regarding the indicators of the WHO Global Benchmarking Tool for evaluating national regulatory systems for medical products, specifically related to the regulatory function of clinical trial oversight.
Promote knowledge sharing among technical experts from NRAs.
Encourage training, deepening, and development of high-impact topics to facilitate the effective implementation of this regulatory function.

:: Affiliated members in 2025

All National Regulatory Agencies are formally invited to join this Forum, conceived as a space for technical exchange and peer-to-peer cooperation.

To date, the following National Regulatory Agencies have joined the Forum as technical members in clinical trial oversight:

Argentina	Administración Nacional de Medicamentos, Alimentos y Tecnología Médica -ANMAT
Brazil	Agência Nacional de Vigilância Sanitária - Anvisa
Chile	Instituto de Salud Pública de Chile - ISP
Colombia	Instituto Nacional de Vigilancia de Medicamentos y Alimentos- INVIMA
Cuba	Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos - CECMED
Ecuador	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria- ARCSA
Ecuador	Ministerio de Salud Pública- MSP
El Salvador	Superintendencia de Regulación Sanitaria
Guatemala	Departamento de Regulación y Control de Productos Farmacéuticos y Afines - DRCPFA
Honduras	Agencia de Regulación Sanitaria- ARSA
Mexico	Comisión Federal para la Protección contra Riesgos Sanitarios - COFEPRIS
Nicaragua	Autoridad Nacional de Regulación Sanitaria-ANRS
PAHO	Pan American Health Organization
Paraguay	Dirección Nacional de Vigilancia Sanitaria -DINAVISA
Peru	Instituto Nacional de Salud - INS

members only access

Evaluation of Clinical Trials

"The primary goal of clinical trial oversight is to protect the safety and rights of human participants, ensuring that studies are properly designed to achieve scientifically valid objectives and to prevent any possibility of fraud or data falsification.

Studies involving health products that will lead to a new marketing authorization or a modification of an existing authorization must obtain prior approval from Ethics Committees and National Regulatory Authorities (NRAs) before initiation. NRAs are responsible for critically evaluating the documentation supporting clinical trials for registration purposes at two key stages:

During the application for authorization to conduct the clinical trial, and monitoring throughout its execution.
When evaluating an application for marketing authorization of the product."

Source: WHO Global Benchmarking Tool for Evaluating National Regulatory Systems for Medical Products

WHO Global Benchmarking Tool

The WHO Global Benchmarking Tool was designed to assess national regulatory systems for medical products. It is structured around indicators and sub-indicators grouped into nine key regulatory functions, one of which is Clinical Trial Oversight (CTO).

It includes descriptive notes for each sub-indicator to guide the evaluation team and ensure consistency in the assessment, documentation, and classification of each sub-indicator.