COFEPRIS, the Federal Commission for Protection against Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios), has been recognized as the National Regulatory Authority of Regional Reference of Medicines and Biological Products by the Pan American Health Organization (PAHO) and the World Health Organization (WHO).
Structurally, the COFEPRIS comprises eight (08) administrative units and four (04) government advisory bodies. The CAS is one of the administrative units of COFEPRIS. CAS stands for Sanitary Authorization Commission, or in Spanish, Comisión de Autorización Sanitaria.
The major responsibilities of CAS revolve around clinical trials. Its responsibilities include the issuance, extension, or revoking of clinical research authorizations. It is responsible for recording, evaluating, and issuing comments on authorization requests for clinical trial protocols. CAS’s tasks are performed by its Technical Area for the Evaluation of Human Research Protocols, also called the Clinical Trials Technical Area (Área de Ensayos Clínicos).
The Clinical Trial Technical Area performs the tasks assigned to CAS through COFEPRIS’s Integral Services Centre (“Centro Integral de Servicios”- CIS). The CIS is a public service system that has been set up to aid the processing of agency procedures and services.
The applicant can submit an application to the CIS to request protocol authorization or for any modifications. Protocol modifications are submitted to reform the research procedures to provide updated clinical and/or preclinical security/safety information or to delete or add research centre(s).
The application can be submitted indirectly to the CIS. The applicant must opt to acquire a pre-assessment evaluation of the application via an Enabled Pre-assessment Support Unit or the Unidad Habilitada de Apoyo al Predictamen (UHAP).
On the other hand, the application can be submitted directly to COFEPRIS. For this, the CIS assigns a reference number to the application and shares this with the CAS for technical evaluation. On receiving a favorable response from the Ethics Committee, the request is approved, and clinical trials are initiated. However, upon receiving a negative remark, the request is rejected, and an objection is issued. The applicant then addresses the issues and can resubmit the request. In either case, the applicant must use the CIS reference number to track the official resolution of authorization or an objection request.
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