Clinical trials in Venezuela are governed by the Ministry of Popular Power for Health (MPPS), with technical review by INHRR (Instituto Nacional de Higiene “Rafael Rangel”) for drugs, biologics, and medical devices, and SACS (Servicio Autónomo de Contraloría Sanitaria) for sanitary control and device registration. Sponsors submit a Spanish protocol package: investigator brochure, informed consent, insurance, and ethics-committee approval. bioaccess® — the first CRO to establish clinical trial operations in Venezuela — runs that submission.
Clinical investigations in Venezuela are governed by MPPS (Ministerio del Poder Popular para la Salud), with technical review by INHRR (Instituto Nacional de Higiene “Rafael Rangel”) for drugs, biologics, and medical devices, and SACS (Servicio Autónomo de Contraloría Sanitaria) for sanitary control and device registration. The instruments behind them, on the INHRR legislación page, include the Ley de Medicamentos (Gaceta Oficial No. 37.006, 3 August 2000), the reglamento de creación del INHRR (Gaceta Oficial No. 4.529, 10 February 1993), the Reglamento Orgánico del MPPS (Gaceta Oficial No. 38.591, 26 December 2006), and the Reglamento de Investigación en Farmacología Clínica of the Junta Revisora de Productos Farmacéuticos.