OC-70: CLINICAL TRIAL, GCP AND CERTIFICATION IN NATURAL PRODUCTS

J Pharm Pharmacogn Res 3(suppl. 1): S82, 2015

Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015  September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.

Oral Communication

OC-70: CLINICAL TRIAL, GCP AND CERTIFICATION IN NATURAL PRODUCTS

Orta D.

Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Calle 5ta A entre 60 y 62, Reparto Miramar, Playa, La Habana, Cuba, C.P.10300. Telef: (537) 2164100, 2164348, 2164347. E-mail: deybis@cecmed.cu

 

The basic function Clinical Trial Authorization in CECMED guarantee protection, benefits, rights and safety of individuals (healthy and diseased) involved in clinical research, as well as a design, conduct and analysis according to scientific principles. The scope includes drugs, biological and natural products. Because of the importance and need to strengthen the clinical development in natural products, the aspects of clinical trials are discussed including the implementation of Good Clinical Practice (GCP) and Certification of GCP in clinical sites that perform these studies. This allows the analysis about knowledge, control and level elevated of exigency of direct and stable way on quality assurance and compliance with GCP. Twenty years of experience CECMED, Cuban Regulatory Authority (MRA), in developing guidelines GCP (1992, 1995 and 2000) with their implementation and control for the National Program of Inspections to Clinical Trials has allowed develop a Certification System for GCP to evaluate and qualify the clinical sites that carry out the requirements for this certification. Since 2008, the regulation 52-08 Requirements for GCP Certification to Sites and/or Clinical Services that perform clinical trials was implemented. This normative started up the GCP Certification System to achieve the identified institutions that met the conditions were certified and prove to the international scientific community that develops and evaluates drugs, credibility and reliability in compliance with GCP and its implementation in Cuba. To evaluate their implementation has been compiled information compliance inspection program for clinical trials and related system between 2008 and 2012, including: inspections, type, institutions, results and issued documents. The training and preparation of institutions and professionals to obtain certification was evaluated. In addition took place the presentation and discussion for this topic in national and international activities. Finally, you can limit the implementation of GCP Certification System has allowed systematic evaluation of compliance GCP in  the institutions involved, the responsibilities of the parties and level of knowledge on the topic and continuous improvement of the activity. Creates the basis for the country to ensure GCP compliance in institutions and recognition, reliability and national and international credibility of this condition.

Citation Format: Orta D (2015) Clinical trial, GCP and certification in natural products. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S82. Abstract nr OC-70.