A comprehensive guide to Venezuela's clinical trial authorization process, covering the roles of MPPS, INHRR, and SACS, the CTA submission process, ethics committee requirements, ICH-GCP compliance, and post-trial obligations for sponsors.
Key Takeaways MPPS (Ministry of Health) sets national health policy and accredits research institutions INHRR (Instituto Nacional de Higiene Rafael Rangel) reviews and approves Clinical Trial Applications (CTAs) and enforces GCP compliance SACS (Servicio Autónomo de Contraloría Sanitaria) handles medical device registration and import authorization The CTA process requires ethics committee approval before INHRR submission All regulatory documents must be submitted in Spanish Foreign sponsors must appoint a local authorized representative — bioaccess® serves this role Pre-submission meetings with INHRR are highly recommended and can reduce review timelines Navigating the regulatory landscape for clinical trials in any new country requires a thorough understanding of the institutions, processes, and requirements involved. In Venezuela, the clinical trial authorization process involves three key entities: MPPS , INHRR , and SACS . This guide provides a comprehensive overview for pharmace…